NATIONAL AQUATIC ANIMAL HEALTH PROGRAM ADMINISTRATIVE RULING No

Ministry of Agriculture, Livestock, and Food Supply Animal and Plant Health and Inspection Secretariat Animal Health Department

Legislation Manual

NATIONAL ANIMAL HEALTH PROGRAMS IN BRAZIL

TECHNICAL MANUAL

MAPA’s Mission: “To promote the sustainable development and the competitiveness of agribusiness to the benefit of Brazilian society.”

Brasília, DF © 2009 Ministry of Agriculture, Livestock, and Food Supply All rights reserved. Reproduction permitted provided the source is cited. The author is responsible for this work’s text and image property rights.

Printing: 5,000 copies First edition. 2009

Preparation, distribution and information: MINISTÉRIO DA AGRICULTURA, PECUÁRIA E ABASTECIMENTO Departamento de Saúde Animal Coordenação Geral de Combate a Doenças Esplanada dos Ministérios, Bloco D, Anexo A, 3º andar, sala 318-A CEP: 70043-900, Brasília-DF Tel.: (61) 3218-2840/2686/2724 Fax: (61) 3226-3446/3224-4180 www.agricultura.gov.br

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This work was produced under a Technical Cooperation Agreement (TCA) celebrated between the Ministry of Agriculture, Livestock, and Food Supply and the Pan-American Foot-and- Mouth Disease Center-PANAFTOSA, Pan-American Health Organization-PAHO, World Health Organization-WHO.

Catalogued at the source National Agricultural Library-BINAGRI

Brazil, Ministry of Agriculture, Livestock, and Food Supply. Legislation Manual: national animal health programs in Brazil / Ministry of Agriculture, Livestock, and Food Supply. Agricultural and Animal and Inspection Office. Animal Health Department. – Brasília: MAPA/SDA/DSA, 2009

440 pp.

ISBAN 978-85-99851-61-6

1. Animal health. 2. Legislation. I. Animal and Plant Health and Inspection Secretariat. II. Animal Health Department. III. Title: National animal health programs in Brazil. AGRIS D50 CDU 351.779 Foreword

The Ministry of Agriculture, Livestock, and Food Supply has successfully endeavored to have animal health care addressed in a coordinated manner by the different government levels. To this end it has sponsored a series of legislative pieces on the preparation of animal health programs. The series consists of administrative rules and normative and services instructions that regulate the programs, so as to ensure comprehensive attention to animal health. These rules and norms have been drawn with wide participation of representatives of professional institutions and of users involved with the issue. As the major tool for carrying out initiatives in the field of Animal Health, the Na- tional Agricultural and Livestock Health and Inspection Policy seeks to establish guidelines and define institutional responsibilities for creating the conditions for the protection of the national herd, as well as preventing harm to public health. This Manual puts together the major legislative pieces that govern this process, issued between 1934 and 2008. The full text of each edition of the Manual is available in digital format on MAPA’s web site. It will be continuously updated as new legislation is enacted. We trust that this Manual will be used by Brazil’s Official Agricultural and Livestock Health and Inspection Services as a valuable source of information and knowledge.

Jamil Gomes de Souza Director, Animal Health Department Summary

part I Background

LAWS AND DECREES 14 LAW No. 9.712 of November 20, 1998 Modifies Law No. 8.171 of January 17, 1991 by adding provisions on agriculture and livestock health and inspection.

16 LAW No. 569 of December 21, 1948 Establishes animal health and inspection measures and makes other provisions. 17 DECREE No. 5.741 of March 30, 2006 Regulates Articles 27-A, 28-A, and 29-A of Law No. 8.171 of January 17, 1991, 4 establishes the Agriculture and Livestock Health Care Unified System, and makes other provisions. 52 DECREE No. 27.932 of March 28, 1950 Approves regulations on the implementation of animal health and inspection measures. 55 DECREE No. 24.548 of July 3, 1934 Approves the Animal Health and Inspection Service’s Internal Regulations. 64 COMPLEMENTARY LEGISLATION

ANIMAL AND PLANT HEALTH AND INSPECTION SECRETARIAT 65 ADMINISTRATIVE RULING No. 45 of March 22, 2007 Approves the Animal and Plant Health and Inspection Secretariat’s Internal Regulations, as hereto annexed. part II Animal Health and Inspection Programs

NATIONAL PROGRAM FOR THE ERADICATION AND PREVENTION OF FOOT-AND-MOUTH DISEASE LAW No. 11515 of August 28, 2007 66 Modifies provisions of Law No. 569 of December 21, 1948, which establishes animal health and inspection measures.

ADMINISTRATIVE RULING No. 4 of January 21, 2000 66 Modifies Annex I of Art. 5 of Administrative Ruling No. 50 of May 19, 1997 ADMINISTRATIVE RULING No. 50 of May 19, 1997 68 Approves the technical criteria for the classification of foot-and-mouth disease risk levels in the States. NORMATIVE INSTRUCTION No. 63 of December 17, 2008 71 Approves the Guidelines for the Implementation of the Veterinary Surveillance System in the Foot-and-Mouth Disease High Surveillance Zones (ZAVs) established along the borders between the State of Mato Grosso do Sul and the Republics of 5 Paraguay and Bolivia, pursuant to the Annex hereto.

NORMATIVE INSTRUCTION No. 53 of November 23, 2007 74 Recognizes and confirms the sanitary status of the States in regard to the foot-and- mouth disease.

NORMATIVE INSTRUCTION No. 44 of October 2, 2007 76 Approves the general guidelines for Foot-and-Mouth Eradication and Prevention, pursuant to Annexes I, II, III, and IV hereto, to be followed throughout the National Territory, with a view to the implementation of the National Program for the Eradication and Prevention of Foot-and-Mouth Disease (PNEFA), as established by the Agriculture and Livestock Health Care Unified System.

COMPLEMENTARY LEGISLATION 96 NATIONAL PROGRAM FOR THE CONTROL AND ERADICATION OF ANIMAL BRUCELLOSIS AND TUBERCULOSIS 99 ADMINISTRATIVE RULING No. 11 of January 26, 2004 Exempts the State of Santa Catarina from the compulsory vaccination of cattle and buffalo females against brucellosis. 100 NORMATIVE INSTRUCTION SDA No. 33 of August 24, 2007 Establishes the conditions for the vaccination of cattle females against brucellosis with a RB51 sample vaccine.

105 NORMATIVE INSTRUCTION No. 41 of November 24, 2006 Approves “Specific Criteria for the Accreditation and Monitoring of Bovine and Bubaline Brucellosis Diagnostic Laboratories.” 118 NORMATIVE INSTRUCTION No. 30 of June 7, 2006 Establishes norms for the qualification of private sector veterinary doctors for carrying out the activities contemplated under the Technical Regulations of the National Program for the Control and Eradication of Animal Brucellosis and Tuberculosis-PNCEBT, as regards performing brucellosis and tuberculosis diagnostic tests, forwarding samples to accredited laboratories, and participating in the certification of raising establishments free of or monitored for bovine and bubaline brucellosis and tuberculosis.

125 NORMATIVE INSTRUCTION No. 6 of January 8, 2004 Approves the Technical Regulations of the National Program for the Control and Eradication of Animal Brucellosis and Tuberculosis-PNCEBT.

6 142 SERVICE INSTRUCTION DDA No. 6 of March 27, 2003 Establishes criteria for recognition of Training Courses on Animal Brucellosis and Tuberculosis Diagnostic and Control Methods and on Notions of Transmissible Spongiform Encephalopathies (TSEs) for accreditation of veterinary doctors under the National Program on the Control and Eradication of Animal Brucellosis and Tuberculosis-PNCEBT.

143 COMPLEMENTARY LEGISLATION NATIONAL HERBIVORE RABIES CONTROL PROGRAM 144 ADMINISTRATIVE RULING SDA No. 168 of September 27, 2005 Approves the Technical Manual for the Herbivorous Rabies Control – 2005 Edition

145 NORMATIVE INSTRUCTION No. 5 of March 1, 2002 Approves Technical Norms for the control of rabies in domestic herbivores.

148 COMPLEMENTARY LEGISLATION NATIONAL PROGRAM FOR THE PREVENTION AND CONTROL OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADMINISTRATIVE RULING No. 516 of December 9, 1997 149 Declares Brazil free of bovine spongiform encephalopathy pursuant to Art. 3.2.13.2 of the International Zoosanitary Code. NORMATIVE INSTRUCTION No. 49 of September 15, 2008 150 Establishes the following categories of risk for Bovine Spongiform Encephalopathy – BSE: Category I – countries with negligible risk of BSE; Category II – countries with controlled risk of BSE; Category III – countries with an undetermined or unclassified risk of BSE. NORMATIVE INSTRUCTION No. 15 of April 2, 2008 152 Approves the Procedures for Action in Suspected Cases of Scrapie. NORMATIVE INSTRUCTION No. 8 of March 25, 2004 159 Forbids in the whole national territory the production, commercialization and use of products destined to the feeding of ruminants that contain in their composition proteins and fat of animal origin. NORMATIVE INSTRUCTION No. 7 of March 17, 2004 160 Prohibits the importation of ruminants, their products and by-products intended to any means, and veterinary products that contain input from ruminants, when coming from countries that have registered domestic cases of BSE, or any other country considered as risk for the disease by the Animal and Plant Health and Inspection Secretariat NORMATIVE INSTRUCTION No. 18 of December 15, 2003 160 7 Forbids the slaughtering of cattle and buffalo imported form countries where autochthonous cases of BSE have occurred or countries considered at risk of such disease

NORMATIVE INSTRUCTION SDA No. 18 of February 15, 2002 167 Approves the Norms that shall be adopted, aiming to increment the epidemiological surveillance for detection of Transmissible Spongiform Encephalopathies – TSE in ruminants

COMPLEMENTARY LEGISLATION 168 NATIONAL AVIAN HEALTH PROGRAM 170 ADMINISTRATIVE RULING No. 147 of June 14, 2006 Establishes a Consultative Technical Committee to help draft technical proposals pertaining to Avian Influenza and Newcastle Disease. 171 ADMINISTRATIVE RULING No. 542 of November 16, 1998 Provides for Hygiene and Sanitary Norms for Qualification of Poultry Farming and Poultry Hatchery for Trade within MERCOSUR. 176 ADMINISTRATIVE RULING No. 115 of October 4, 1995 Defines the attributions of the National Avian Health Policy-PNSA’s Scientific Committee 176 ADMINISTRATIVE RULING No. 193 of September 19, 1994 Institutes the National Avian Health Program, in the sphere of the Animal and Plant Health and Inspection Secretariat – SDA and creates the Advisory Committee for the Avian Health Program 177 ADMINISTRATIVE RULING No. 70 of March 3, 1994 Regulates the enforcement of notification of suspected Newcastle Disease 177 NORMATIVE INSTRUCTION No. 56 of December 4, 2007 Establishes Procedures for the Registration, Inspection and Control of Comercial and Poultry Breeding Establishments 194 NORMATIVE INSTRUCTION No. 17 of April 7, 2006 Approves within the scope of the National Avian Health Program, the National Plan for the Prevention of Avian Influenza and Control and Prevention of Newcastle Disease. 8 200 NORMATIVE INSTRUCTION No. 78 of November 3, 2003 Approves the Technical Rules for the Control and Certification of Poultry holdings and Nucleis, such as, free of Salmonella gallinarum and of Salmonella pullorum, and free or controlled for Salmonella enteritidis and Salmonella typhimurium 208 NORMATIVE INSTRUCTION No. 11 of September 1, 2003 Declares the industrial avian flocks in the States of Rio Grande do Sul, Santa Catarina, Paraná, São Paulo, Minas Gerais, Goiás, Mato Grosso do Sul, Mato Grosso, and of the Federal District free of Newcastle disease. 208 JOINT NORMATIVE INSTRUCTION No. 2 of February 21, 2003 Provides for the approval of technical regulations for registration, inspection, and sanitary control of ratite incubation, breeding, and housing establishments. 221 NORMATIVE INSTRUCTION SDA No. 32 of May 13, 2002 Approves the technical rules of surveillance for the Newcastle disease and avian influenza, and of control and eradication of the Newcastle disease NORMATIVE INSTRUCTION No. 44 of August 23, 2001 232 Approves the Technical Rules for the Control and the Certification of Aviary Centers and Establishment for the Aviary Mycoplasmosis (Mycoplasma gallisepticum, synoviae and melleagridis). SERVICE INSTRUCTION DDA No. 1 of December 14, 1999 239 Requirements for the entry of Pet Birds into the National Territory. COMPLEMENTARY LEGISLATION 239

NATIONAL AQUATIC ANIMAL HEALTH PROGRAM ADMINISTRATIVE RULING No. 573 of June 4, 2003 240 Establishes the National Aquatic Animal Health Program

NORMATIVE INSTRUCTION No. 18 of May 13, 2008 241 Establishes procedures for the importation of aquatic animals for ornamental purposes and destined for sale. NORMATIVE INSTRUCTION No. 53 of July 2, 2003 243 Approves Technical Regulations of the National Aquatic Animal Health Program. NORMATIVE INSTRUCTION No. 39 of November 4, 1999 249 Temporarily suspends the admission into the national territory of all crustacean species, whether salt or fresh water, at any development stage of their biologic 9 cycle, whether fresh, frozen, or cooked, whole in their carapaces or parts thereof, from any origin.

NATIONAL CAPRINE AND OVINE HEALTH PROGRAM NORMATIVE INSTRUCTION No. 20 of August 15, 2005 250 Approves the Procedures for the Operationalization of the Sanitary Register of Goat and Sheep Raising Establishments. NORMATIVE INSTRUCTION No. 87 of December 10, 2004 255 Approves the National Caprine and Ovine Health Program Technical Regulations. COMPLEMENTARY LEGISLATION 259 NATIONAL BEEKEEPING HEALTH PROGRAM 259 NORMATIVE INSTRUCTION No. 16 of May 8, 2008 Establishes the National Beekeeping Health Program-PNSAp under the Ministry of Agriculture, Livestock, and Food Supply. 260 COMPLEMENTARY LEGISLATION

NATIONAL EQUID HEALTH PROGRAM 260 NORMATIVE INSTRUCTION No. 17 of May 8, 2008 Establishes the National Equid Health Program-PNSE under the Ministry of Agriculture, Livestock, and Food Supply. 261 NORMATIVE INSTRUCTION No. 45 of June 15, 2004 Approves Norms for the Prevention and Control of Equine Infectious Anaemia - EIA. 272 NORMATIVE INSTRUCTION No. 24 of April 5, 2004 Approves Norms on Glanders Control and Eradication 278 NORMATIVE INSTRUCTION No. 12 of January 29, 2004 Defines Quality Criteria for Accreditation and Monitoring of Laboratories for Glanders Serologic Diagnostic based on the Complement Fixation Technique. COMPLEMENTARY LEGISLATION 10 296

NATIONAL SWINE HEALTH PROGRAM 297 NORMATIVE INSTRUCTION No. 8 of April 3, 2007 Approves the Rules for the Control and Eradication of Aujeszky’s Disease (AD) in domestic pigs, to be complied with all over the national territory. 327 NORMATIVE INSTRUCTION No. 47 of June 18, 2004 Approves the National Swine Health Program’s (PNSS) Technical Regulation in the form of the annex to this Normative Instruction. 330 NORMATIVE INSTRUCTION No. 27 of April 20, 2004 Approves the Contingency Plan for Classical Swine Fever, which shall be effective throughout the national territory, as provided for in the Annex to this Normative Instruction. NORMATIVE INSTRUCTION No. 6 of March 9, 2004 346 Approves the Rules for Eradication of the Classical Swine Fever (CSF), which shall be complied with throughout the entire National Territory, in the manner described in this Normative Instruction.

NORMATIVE INSTRUCTION SDA No. 19 of February 15, 2002 351 Standards for Accreditation of Swine Breeding Farms COMPLEMENTARY LEGISLATION 360

part III Animal Movement and Quarantine Control

ADMINISTRATIVE RULING No. 162 of October 18, 1994 361 Approves complementary Norms attached to this Administrative Ruling, issued by 11 the Animal Health and Inspection Department, which deal with Inspection and Animal Health Control in Exhibitions, Agricultural Fairs, Auctions and other livestock agglomerations, throughout the national territory.

NORMATIVE INSTRUCTION No. 46 of September 2, 2008 366 Approves procedures for importation of genetic material intended for the restitution of poultry stocks of chickens (Gallus gallus), guinea fowl (Numida meleagris), turkeys (Meleagris gallopavo), quails (Coturnix coturnix), palmiped birds (ducks, gooses and widgeons), pheasants (Phasianus colchicus) and partridges (genus Alectoris). NORMATIVE INSTRUCTION No. 40 of September 4, 2007 373 Sets the sanitary requirements for importing bovine and bubaline semen from countries outside Mercosul. NORMATIVE INSTRUCTION No. 18 of July 18, 2006 377 Approves the Animal Movement Permit (GTA) model to be used throughout Brazil for the transportation of live animals, fertile eggs and other materials related to animal multiplication.

382 NORMATIVE INSTRUCTION No. 8 of March 10, 2006 Incorporates into the national legislation the Zoosanitary Requirements for the exchange of Bovine and Bubaline Semen among the State Parties. 388 NORMATIVE INSTRUCTION No. 80 of November 11, 2004 Incorporates into national legislation “Zoosanitary and Embarkation Certificate Models and Zoosanitary Requisites for the Exchange of Cattle for Rearing and Fattening between Member States of MERCOSUL,” approved by MERCOSUL GMC Resolution No. 31/03 that counts as an annex to this Normative Instruction. 394 NORMATIVE INSTRUCTION No. 69 of September 15, 2004 Incorporates into national legislation “Zoosanitary and Embarkation Certificate Models and Zoosanitary Requisites for the Exchange of Cattle and Buffalos for Reproduction between Member States of MERCOSUL.”

399 NORMATIVE INSTRUCTION No. 61 of August 30, 2004 Incorporates to the national legislation the “Zoosanitary requirements for the Exchange of Cattle for Immediate Slaughter among the Member States of the Mercosur and the Zoo-sanitary Certificate and Embarkation Certificate Models.”

403 NORMATIVE INSTRUCTION SDA No. 48 of June 17, 2003 Bovine and bubaline semen may be distributed in Brazil only if collected at Semen Collection and Processing Centers-SCPC registered with the Ministry of Agriculture, Livestock, and Food Supply and which are in compliance with minimum requirements for the production and marketing of bovine and bubaline semen in the country. 406 NORMATIVE INSTRUCTION No. 17 of April 10, 2003 Incorporates into the national legislation the “Zoosanitary Requirements and Certificates for Goat Trade among Mercosur State Parties.” 12 418 NORMATIVE INSTRUCTION SDA No. 54 of September 17, 2002 Approves zoosanitary requirements for the importation of swine semen. Not applicable to Mercosur States Parties. 420 NORMATIVE INSTRUCTION SDA No. 39 of June 17, 2002 Adopts Resolution GMC-Mercosur No. 51/01, which approved the “Zoosanitary Requirements for Sheep Trading among Mercosur State Parties.” 433 NORMATIVE INSTRUCTION No. 31 of May 10, 2002 All pigs imported must be accompanied by a Zoosanitary Certificate warranting the compliance with the conditions required by the Ministry of Agriculture, Livestock and Food Supply of Brazil.

437 COMPLEMENTARY LEGISLATION 13 part I Background

LAWS AND DECREES

LAW No. 9712 OF NOVEMBER 20, 1998

Published in the Federal Official Gazette of 23 November 1998, Section 1, Page 1

Modifies Law No. 8171 of January 17, 1991, by adding to it provisions on agriculture and livestock health and inspection.

THE PRESIDENT OF THE REPUBLIC agricultural and livestock activities. The NATIONAL CONGRESS has decreed and I Paragraph 2. The activities listed in the pre- have sanctioned the following Law: ceding paragraph are organized so as to ensure compliance with current legislation on agricul- Art. 1. Chapter VII of Law No. 8171 of Janu- ture and livestock health and inspection and ary 17, 1991, enters into force with the following with international commitments undertaken by articles: the Brazilian Government.” “Art. 27-A. The objective of agriculture and “Art. 28-A. To promote health, animal and livestock health and inspection is to ensure: plant health surveillance and heath and inspec- I – The health of plant populations; tion actions shall be organized, under the co- II – The health of animal herds; ordination of the different government levels, III – The suitability of inputs and services for pursuant to their competence, into a Agriculture agriculture and livestock use; and Livestock Health Care Unified System , coor- 14 IV – The identity and hygienic, sanitary, and dinated in turn, as regards public health, with technological safety of final agricultural and live- the Unified Health System established under stock products destined for consumers. Law No. 8080 of September 19, 1990, with the Paragraph 1. To ensure the achievement of participation of: the aforementioned objectives, the Government I – Official services and institutions; will carry out the following activities on a con- II – Rural producers and workers, their as- tinuing basis: sociations, and technicians that assist them; I – Plant health surveillance and health and III – Oversight bodies of professional cat- inspection; egories directly connected with agriculture and II – Animal health surveillance and heath livestock health and inspection; and inspection; IV – Management of funds set up by the pri- III – Inspection and classification of plant vate sector to complement government actions products, their byproducts, subproducts, and in the field of agriculture and livestock health. residues of economic value; Paragraph 1. The municipal area shall be IV – Inspection and classification of animal considered the basic geographical unit for the products, their byproducts, subproducts, and organization and operation of the agriculture residues of economic value; and and livestock health official services. V – Inspection of inputs and services used in Paragraph 2. The Local Organ of the Agri- culture and Livestock Health Care Unified System V – Evaluation of actions carried out by local shall provide comprehensive health care within and Intermediate Organs of the Agriculture and its jurisdiction, with the participation of the or- Livestock Health Care Unified System ; ganized community, particularly as regards the VI – Representing the country at interna- following activities: tional forums dealing with Agriculture and Live- I – Establishment of a property register; stock Health and Inspection; II – Inventory of animal and plant popula- VII – Undertaking epidemiologic studies tions; and supporting the development of the Ag- III – Animal and plant movement control; riculture and Livestock Health Care Unified IV – Establishment of a register of active System ; health professionals; VIII – Technical cooperation provided to V – Establishment of a register of businesses other Agriculture and Livestock Health Care Uni- selling products for agronomic and veterinary use; fied System Organs; VI – Establishment of a register of disease IX – Improvement of the Agriculture and diagnostic laboratories; Livestock Health Care Unified System ; VII – Inventory of diagnosed diseases; X – Coordination of the Agriculture and Live- VIII – Launching of disease control cam- stock Health Care Unified System ; paigns; XI – Maintenance of the Agriculture and IX – Education and Health surveillance; Livestock Health and Inspection Code. X – Participation in disease and pest eradi- Paragraph 5. Management of funds set up cation projects. by the private sector to complement govern- Paragraph 3. The following activities shall ment actions in the area of Agriculture and be incumbent upon the Agriculture and Live- Livestock Health and Inspection shall form part stock Health Care Unified System ’s Intermediate of the Agriculture and Livestock Health Care Organs: Unified System. I – Surveillance of the interstate movement Paragraph 6. Strategies and policies aimed of plants and animals; at promoting health and surveillance shall be II – Coordination of disease and pest control ecosystemic and decentralized according to and eradication campaigns; types of health problem so as to ensure pest- III – Maintenance of nosographic reports; and disease-free areas, pursuant to interna- 15 IV – Coordination of epidemiologic actions; tional agreements and treaties of which Brazil V – Coordination of sanitary education ac- is a signatory. tions; Paragraph 7. Whenever epidemiologically VI – Oversight of the diagnostic network and recommended, the eradication of diseases and of accredited health professionals. pests shall have priority under the pest- and dis- Paragraph 4. The following activities shall ease-free areas strategy.” be incumbent upon the Agriculture and Live- “Art. 29-A. Industrial and health inspection stock Health Care Unified System ’s Central and of plant and animal products and of agricultural Superior Organ: and livestock inputs shall be managed so that I – Surveillance of ports, airports, and inter- inspection procedures and organization shall be national border checkpoints; universal and equitably applied to all inspected II – Establishment of norms pertaining to establishments. disease and pest control and eradication cam- Paragraph 1. Inspection may follow the haz- paigns; ard analysis and critical control points method. III - Approval of diagnostic methods and Paragraph 2. As part of the Agriculture and products of veterinary and agronomic use; Livestock Health Care Unified System , a Brazil- IV – Maintenance of the epidemiologic infor- ian plant product inspection system and a Bra- mation system; zilian animal product inspection system shall be established, as well as specific inspection within ninety days of its publication. systems for agricultural and livestock inputs.” Art. 3. This Law shall enter into force on the Art. 2. The Executive shall regulate this Law date of its publication.

Brasília, the twentieth day of November of the year 1998, the 177th of Independence and the 110th of the proclamation of the Republic.

FERNANDO HENRIQUE CARDOSO FRANCISCO SÉRGIO TURRA

LAW No. 569 OF DECEMBER 21, 1948

Published in the Federal Official Gazette of December 23, 1948, Section 1, Page 18256

Establishes animal health and inspection measures and makes other provisions.

THE PRESIDENT OF THE REPUBLIC, make premises shall be equal to the total amount es- known that the NATIONAL CONGRESS has decreed tablished by the assessment. and I have sanctioned the following Law: Art. 5. The assessment shall be done by a Art. 1. Whenever the sanitary slaughter of dis- commission consisting of Federal Government eased animals or the destruction of rural items or representatives, who must be veterinary profes- facilities is determined to safeguard public health, sionals, a State Government representative, and their owner shall be entitled to a cash indemnity a representative of the Rural Associations estab- established by prior assessment. lished under Decree-law no. 7449 of April 9, 1945, Sole Paragraph. Should the assessment de- who may be replaced in regions where such asso- termine that a part of the rural items or facilities ciations do not exist by a ruralist of known tech- is fit for use, a proportionate amount shall be de- nical capacity, appointed by the interested party. 16 ducted from the indemnity. Sole Paragraph. The report may be appealed Art. 2. Animals affected by any of the within thirty days to the Minister of Agriculture by: zoonoses specified under Art. 63 of the Animal (a) the Federal Government representative, if he Health and Inspection Service Regulations ap- deems the indemnity excessive or unacceptable; proved by Decree No. 24548 of July 3, 1934 shall (b) the owner of the animal or rural items or be sanitary slaughtered. premises if the indemnity is denied or considered Sole Paragraph. No indemnity shall be due insufficient by the assessment commission. in case of rabies, pseudorabies, or any other dis- Art. 6. The indemnity shall be paid by the ease considered incurable and lethal. Federal Government under a specific budget ap- Art. 3. The indemnity due for a sanitary propriation, additional credit for the same pur- slaughtered animal shall be paid on the follow- pose, or budget appropriation for expenditures ing basis: with prophylaxis and combating epizooties. (a) a fourth of the animal’s value, in case of Sole Paragraph. Should there be an agree- tuberculosis; ment between the Federal Government and a (b) half of the animal’s value, in other cases; Sate with the contribution of another entity for (c) the full value of the animal if the the execution of public animal health and inspec- necropsy or another procedure fails to confirm tion services, one third of the indemnity shall be the clinic diagnostic. paid by the State and the remaining two thirds Art. 4. The indemnity due for rural items or shall be paid by the Federal Government; Art. 7. The right to enter an indemnity claim the requisite regulations for this Law’s enforcement. shall expire ninety days as of the date of the ani- Art. 9. This Law shall enter into force ninety mal’s death or item’s destruction. days as of its publication; all provisions to the Art. 8. The Executive shall issue within sixty days contrary are hereby revoked.

Rio de Janeiro, the twenty-first of December of the year 1948, the 127th of Independence and the 60th of the proclamation of the Republic.

EURICO G. DUTRA Daniel Carvalho Corrêa Castro

DECREE No. 5741 OF MARCH 30, 2006

Published in the Federal Official Gazette of March 31, 2006, Section 1, Page 82

Regulates Articles 27-A, 28-A, and 29-A of Law No. 8171 of January 17, 1991, establishes the Agriculture and Livestock Health Care Unified System, and makes other provisions.

THE PRESIDENT OF THE REPUBLIC, by virtue and 29-A of Law no. 8171 of January 17, 1991 is of the powers vested in him under Art. 84, IV and hereby regulated pursuant to the Annex hereto. VI, a of the Constitution, having in view the provi- Art. 2. It is incumbent upon the Minister of sions of Arts. 27-A, 28-A, and 29-A of Law no. 8171 Agriculture, Livestock, and Food Supply to issue of 17 January 1991, the complementary acts and norms called for under the Regulations hereby approved. (NR) DECREES: Art. 3. This Decree enters into force on the Art. 1. The Regulation of Arts. 27-A, 28-A, date of its publication.CAPÍTULO I

Brasília, the thirtieth of March of the year 2006; the 185th of Independence and the 118th of the 17 proclamation of the Republic.

LUIZ INÁCIO LULA DA SILVA Roberto Rodrigues Miguel Soldatelli Rosseto

ANNEX

REGULATION OF ARTS. 27-A, 28-A, AND 29-A OF LAW No. 8171 OF JANUARY 17, 1991

CHAPTER I Paragraph 1. Participants in the Agriculture and Livestock Health Care Unified System shall be PRELIMINARY DISPOSITIONS as follows: I – Official services and institutions; Art. 1. The Agriculture and Livestock Health II – Rural producers and workers, their asso- Care Unified System is hereby established pursuant ciations, and technicians that assist them; to these Regulations. III – Oversight bodies of professional categories directly connected with agriculture and live- ity of inputs and services for agricultural and stock health; and livestock use; and the identification and hy- IV – Management of funds set up by the pri- gienic, sanitary, and technological safety of fi- vate sector to complement government actions in nal agricultural and livestock products destined the field of agriculture and livestock health. for consumers. Paragraph 2. The Agriculture and Livestock Paragraph 2. The Agriculture and Livestock Health Care Unified System operates in accor- Health Care Unified System operates in and in- dance with the principles and definitions of agri- tegrated form to guarantee agriculture and live- culture and livestock Health, including the con- stock health an safety, from the primary produc- trol of activities pertaining to health, oversight, tion location to the placement of the final prod- inspection, education, and to the surveillance uct on the internal or on the export market. of animals, plants, and animal and plant inputs Paragraph 3. Rural producers, industrialists, and products. and input suppliers, distributors, cooperatives Paragraph 3. The Agriculture and Livestock and associations, industrialists and agroindustri- Health Care Unified System shall carry out the fol- alists, wholesalers and retailers, importers and lowing activities on a continuing basis: exporters, entrepreneurs and any other agribusi- I – surveillance and plant health and inspec- ness operators along the production chain are re- tion; sponsible for ensuring that the health and quality II – surveillance and animal health and in- of animal and plant products and the agricultural spection; and livestock inputs will not be compromised. III – inspection and classification of plant Paragraph 4. Undertaking official controls products, byproducts, subproducts, and residues pursuant to these Regulations does not exempt of economic value; participants in the production chain from the IV – Inspection and classification of animal legal and principal obligation to ensure the products, their byproducts, subproducts, and health of animals and of plants, the safety and residues of economic value; and quality of animal and plant products, as well as V – Inspection of inputs and services used in agricultural and livestock inputs; neither does it agricultural and livestock activities. prevent the performance of new controls nor ex- Paragraph 4. The Agriculture and Livestock empts participants from civil or penal liability for Health Care Unified System shall be coordinated failure to comply with their obligations. 18 with the Unified Health System in matters- per Paragraph 5. Rural producers and other taining to public health. participants in production chains shall cooperate with the competent authorities to ensure the Section I effectiveness of official controls and improve ag- Principles and General Obligations riculture and livestock healthiness. Art. 2. The norms and procedures of the Ag- Paragraph 6. Health control procedures riculture and Livestock Health Care Unified Sys- shall include traceability of animal and plant tem conform to the principles to be observed in products, agricultural and livestock inputs and connection with agriculture and livestock health, their ingredients, and raw materials throughout especially with those pertaining to the duties in- the production chain. cumbent upon producers, manufacturers, and Paragraph 7. Complementary agriculture competent authorities, including agriculture and and livestock health and inspection norms stem- livestock health’s structural and operational re- ming from these Regulations shall be based on quirements. scientific knowledge. Paragraph 1. The objective of the Agricul- Paragraph 8. Importation and exportation ture and Livestock Health Care Unified System’s of animals and plants, animal and plant prod- general and specific norms is to ensure the pro- ucts, agricultural and livestock inputs and their tection of animal and plant health the suitabil- ingredients, as well as of raw materials shall abide by these Regulations’ provisions. VI – Guarantee that imported animals, Art. 3. The municipality’s area shall be the plants, agricultural and livestock inputs and ani- basic geographical area of the Agriculture and mal and plant products meet the same health Livestock Health Care Unified System’s structure and quality criteria required in Brazil or equiva- and of the operation of official agriculture and lent criteria; livestock health services. VII – Prevention, elimination, or reduction Art. 4. These regulations shall apply to the of hazards to acceptable levels; production, processing, and distribution stages VIII –Compliance with zoosanitary and phy- and to the official agriculture and livestock ser- tosanitary norms; vices, without prejudice to specific requirements IX – Compliance with official sampling and to ensure agriculture and livestock health and analysis methods; and the quality, origin, and identity of agricultural X – Compliance with any other require- and livestock products and inputs. ments established by the agriculture and live- Art. 5. Production chain participants shall stock health legislation. provide the following information to the compe- Paragraph 1. The official sampling and tent authority in the form required by the latter: analysis methods to be used as reference shall I – Name and characteristics of establish- be established under a specific norm. ments under their controls which are devoted Paragraph 2. While official sampling or to any of the production, processing, and distri- analysis methods are still pending, partici- bution stages, and of agriculture and livestock pants may use other methods that are scien- services; tifically validated according to internationally II – Current data about their establishments, accepted norms or protocols. including notification of any significant change Art. 7. The Ministry of Agriculture, Livestock, in their activities, or their closing; and and Food Supply shall establish specific norms III – Occurrence of changes in health and pertaining to agriculture and livestock health phytosanitary conditions in their establishments, and inspection for: production units, or properties. I – Rural primary production for self-con- Art. 6. These Regulations establish norms sumption and the domestic preparation, han- aimed at participants in the Agriculture and dling, or storage of agricultural and livestock Livestock Health Care Unified System as well as products for family consumption; 19 norms pertaining to the undertaking of official II – Sale or bulk or retail supplying of small controls to verify compliance with agriculture quantities of primary production products di- and livestock health legislation and the quality rectly to the end-consumer by family farmers or of agricultural and livestock products and inputs, their equivalent; and taking the following into consideration: III – Agroprocessing done on a family farm- I – Guarantee of animal health and plant ing rural property or its equivalent. healthiness; Sole Paragraph. The application of specific II – Guarantee of the healthiness, quality, and norms referred to in this article’s heading is sub- safety of animal and plant products along the project to the minimum risk of circulation and dis- duction chain, starting with primary production; semination of regulated pests and diseases. III – Maintenance of the cold chain, espe- Art. 8. These regulations do not exempt par- cially for frozen or perishable animal and plant ticipants in the production chain from compli- products that cannot be safely stored at room ance with any specific disposition pertaining to temperature; other federal, state, and municipal official con- IV – Overall application of the procedures trols unrelated to agriculture and livestock health based on the Hazard Analysis and Critical Control and inspection. Points-HACCP and on risk analysis; Sole Paragraph. Federal official controls re- V – Observance of microbiologic criteria; ferred to in the preceding include provisions pertaining to hygiene and sanitary control under the ficial controls throughout the production chains; Unified Health System (SUS). II – The hiring, through competitive examination, of personnel to perform official controls; CHAPTER II III – The absence of any conflict of interest on the part of the personnel that undertake AGRICULTURE AND LIVESTOCK HEALTH IV – Existence of or access to laboratories CARE UNIFIED SYSTEM with sufficient capacity to perform tests, staffed with qualified, experienced personnel in suf- Section I ficient number to perform official controls effi- Organs ciently and effectively; Art. 9. Agriculture and Livestock Health Care V – The availability, adequateness, and prop- Unified System activities shall be carried out by a er maintenance of facilities and equipment to Central and Superior Organ and by Intermediary ensure that the staff will be able to undertake of- and Local Organs. ficial controls with assurance and effectiveness; Paragraph 1. It shall be incumbent on the VI – The assurance of the requisite legal pow- Central and Superior Organ to carry out activities ers to undertake official controls and to adopt that are incumbent exclusively on the Federal measures contemplated hereunder; and Government pertaining to policy, strategy, norms, VII – The existence of emergency and contin- regulation, coordination, oversight, audit, verifi- gent plans, and staff prepared for executing such cation, or inspection, including operational activi- plans. ties if required by national or regional interest. Paragraph 7. The competent authorities of Paragraph 2. It shall be incumbent on the the three Organs shall guarantee the impartiality, Intermediary Unit to carry out activities per- quality, and consistence of official controls. taining to strategy, norms, regulation, coordi- Art. 10. The authorities in the three Organs nation, and operation of interest to the Federal shall ensure that official controls are regularly Government as well as activities exclusive to the undertaken, consistently with existing or poten- State in their respective jurisdictions, pursuant tial agriculture and livestock health risks and as to pertinent federal, state, and Federal District frequently as is appropriate for achieving these regulations. Regulations’ objective, particularly in connection Paragraph 3. It shall be incumbent on the Lo- with the following: 20 cal Organs to carry out actions of interest to the I – Identified or associated risks; Federal Government, the States, or the Municipali- II – Background of those responsible for pro- ties pursuant to pertinent federal, state , or munici- duction or processing; pal legislation. III – Reliability of self-controls; and Paragraph 4. It shall be incumbent on par- IV – Signs of noncompliance with these Regu- ticipants in the Agriculture and Livestock Health lations or with specific legislation. Care Unified System to see to full compliance with Art. 11. At the competent authority’s discre- current specific legislation that regulates agricul- tion, official controls may be undertaken at any ture and livestock health and inspection activities, stage of production, processing, storage, transpor- obligations, and commitments undertaken under tation, and distribution, and shall cover the inter- international agreements. nal market as well as exports and imports. Paragraph 5. Control activities carried out Paragraph 1. The competent authorities of by the competent authorities of the three Organs each Organ shall verify compliance with the legis- are considered direct Government activities. lation through non-discriminatory controls; Paragraph. 6. It shall be incumbent on the Paragraph 2. To establish official controls, competent authorities of the three Organs to en- the competent authorities of each Organ shall re- sure the following: quest from producers documents and additional I – The effectiveness and adequateness of of- information on their products. Paragraph 3. Should any case of noncompli- the deadline established in Paragraph 2 above to ance be detected during the undertaking of an of- support agriculture and livestock health and in- ficial control at the destination point or during stor- spection management, which is incumbent upon age or transportation, the competent authorities of the Central and Superior Organ. each Organ shall adopt the appropriate measures. Art. 14. The following shall be incumbent Paragraph 4. Audits, inspections, and con- upon the Agriculture and Livestock Health Care trols shall be done without prior notice, except in Unified System’s Central and Superior Organ: specific cases, when prior notification of the per- I –Agriculture and livestock surveillance of son responsible for the establishment or services ports, airports, and international border check- shall be obligatory. points, and special customs posts; Art. 12. Any adaptation, formulation, or II – Establishment of norms pertaining to modification of the agriculture and livestock plant pest and animal disease control and eradi- health and inspection norms shall conform to cation campaigns; these Regulations so as to ensure the continuous III – Approval of diagnostic methods and of improvement of the Agriculture and Livestock products for veterinary and agronomic uses; Health Care Unified System. IV – Maintenance of the epidemiologic data system; Section II V – Regulation, regularization, introduction, The Central and Superior Organ implementation, coordination, and evaluation of Art. 13. The Central and Superior Organ’s activities pertaining to sanitary education in agri- activities shall be carried out by the Ministry of culture and livestock health and inspection at the Agriculture, Livestock, and Food Supply and its three Organs of the Unified System; collegiate bodies set up by and subject to the Na- VI – Auditing, oversight, evaluation, and co- tional Agricultural Policy Council pursuant to Art. ordination of activities carried out by Intermedi- 5 of Law No. 8171 of January 17, 1991. ary and Local Organs; Paragraph 1. It shall be incumbent upon the VII – Representing Brazil at international National Agricultural Policy Council to ensure that forums that deal with agriculture and livestock the collegiate bodies are set up with the participa- health and inspection; tion of representatives from the government and VIII – Undertaking epidemiologic studies and civil society and to guarantee their democratic studies in support of the development of the Agri- 21 functioning, while harmonizing the interests of culture and Livestock Health Care Unified System; the Federal Government and of all system par- IX – Improvement of the Agriculture and ticipants, as well as approving the bylaws of the Livestock Health Care Unified System. collegiate bodies. X- Technical cooperation with the other Or- Paragraph 2. The Ministry of Agriculture, gans of the Agriculture and Livestock Health Care Livestock, and Food Supply as the Central and Su- Unified System; perior Organ shall establish the collegiate bodies XI – Maintenance of agriculture and livestock within a maximum of ninety days as of the setting- health and inspection norms; and up of the National Agricultural Policy Council. XII – Execution and operationalization of cer- Paragraph 3. The Ministry of Agriculture, tification and of agriculture and livestock surveil- Livestock, and Food Supply’s decentralized units lance in areas under its jurisdiction. – the Federal Agriculture, Livestock, and Supply Art. 15. As the Agriculture and Livestock Superintendences and the National Agriculture Health Care Unified System’s Central and Superior and Livestock Laboratories – shall form part of Organ, the Ministry of Agriculture, Livestock, and the Central and Superior Organ. Food Supply is responsible for: Paragraph 4. As the Central and Superior I – Establishing the sanitary and phytosani- Organ, the Ministry of Agriculture, Livestock, and tary regulations for the importation and exporta- Food Supply shall set up Executive Committees by tion of animals and plants and of parts, products, and subproducts thereof, organic matter, biologic ficial controls require the intervention of more organisms, and other items that are regulated be- than one of the Intermediate Organs; cause of the risk associated with the introduction VII – Cooperate with other services or depart- and dissemination of pests and diseases; ments that may have responsibilities in this field; II – Organizing, conducting, preparing, and VIII – Verify the conformity of sampling meth- homologating pest and disease risk analysis per- ods, analysis methods, and detection tests; and taining to the importation and exportation of IX – Develop or promote other activities and products and raw materials; generate information needed for the effective III – Promoting the accreditation of cooperat- functioning of official controls. ing centers; IV – Participating in the development of in- Section III ternational standards pertaining to sanitary and Intermediate Organs phytosanitary requirements and to pest and dis- Art. 19. The Intermediate Organs’ activities ease risk analysis; shall be carried out in each State by the agency V – Managing, compiling, and processing that has the mandate or attribution for carrying pest and disease associated risk information; and out agriculture and livestock Health and Inspec- VI – Promoting training activities in connection activities. tion with issues related to risks associated with Paragraph 1. The Intermediate Organs’ ac- pests and diseases. tivities may be carried out by institutions defined Art. 16. As the Agriculture and Livestock Health by the State or Federal District governments; such Care Unified System’s Central and Superior Organ, institutions may represent: the Ministry of Agriculture, Livestock, and Food I – Geographical regions; Supply shall establish the operating norms, specify- II – Groups of States, individual States, or the ing the Agriculture and Livestock Health Care Uni- Federal District; fied System’s activities within its competence. III – Production poles; or Art. 17. The States and the Municipalities IV – A specific geographical region. shall provide the information requested by the Paragraph 2. The Intermediate Organs shall Ministry of Agriculture, Livestock, and Food Sup- appoint the competent authorities to be respon- ply as the Central and Superior Organ. sible for the achievement of the objectives and Art. 18. To put into operation and control for the fiscal controls contemplated hereunder. 22 the Agriculture and Livestock Health Care Uni- Paragraph 3. Should an Intermediary Or- fied System, the Ministry of Agriculture, Live- gan delegate the competence for undertaking stock, and Food Supply as its Central and Supe- official controls to an authority or to authori- rior Organ, shall: ties of another Intermediate Unit, or to an I – Organize and define relations among au- institution, the delegating Organ shall ensure thorities of the Agriculture and Livestock Health the efficient and effective coordination of all Care Unified System; activities involved. II – Establish the objectives and goals to be Art. 20. The following activities shall be in- achieved; cumbent upon the Intermediate Organs: III – Define staff functions, responsibilities, I – Agriculture and livestock surveillance of and duties; interstate movement of animals and plants; IV – Establish sampling procedures, methods II – Coordination and execution of programs and techniques of control and interpretation of and campaigns on the control and eradication of results, and related decisions; plant pests and animal diseases; V – Develop programs for the follow-up of III – Maintenance of nosographic reports; official controls and agriculture and livestock sur- IV – Coordination and execution of epide- veillance; miologic actions; VI – Support mutual assistance whenever of- V – Coordination and execution of programs, projects, and activities of sanitary education in nesses selling products for agronomic and vet- their area of operation; and erinary use; VI – Control of the diagnostic network and of VII – Establishment of a register of disease accredited health professionals. diagnostic laboratories; Art. 21. Each Intermediary Organ shall adopt VIII – Inventory of diagnosed diseases and the requisite measures to ensure that control pro- pests; cedures are followed in an equivalent manner in IX – Launching of disease and pest control all Municipalities and Local Organs. campaigns; Paragraph 1. The competent authority in X – Sanitary surveillance education; each State shall verify compliance with the leg- XI – Participation in disease and pest eradi- islation through nondiscriminatory controls. cation projects; and Paragraph 2. Should any case of noncom- XII – Implementation of disease and pest pliance be detected during the undertaking of eradication programs. an official control at the destination point or Paragraph 2. Local Organs shall appoint the during storage or transportation, the compe- competent authorities to be responsible for the tent authorities of each Organ shall adopt the achievement of the objectives and for the official appropriate measures. controls contemplated hereunder. Art. 22. The Intermediate Organs shall coor- Art. 24. A Local Organ may have more than dinate and compile data on agricultural and live- one post to assist rural producers and the com- stock health activities in their areas of operation. munity in connection with agriculture and livestock health and inspection. Section IV Art. 25. Local Organs shall be responsible, Local Organs through their offices to assist the community and Art. 23. Local Organ activities shall be car- the agriculture and livestock health care posts, ried out by the local agriculture and livestock for notifying events pertaining to agriculture and health unit, which shall be connected to the livestock health and inspection. Intermediate Organ, as defined by the Ministry of Agriculture, Livestock, and Food Supply as the CHAPTER III Central and Superior Organ, and may encompass one or more than one basic geographical unit PROCEDURES AT THE DIFFERENT ORGANS 23 and Municipality, including microregions, micro- OF THE AGRICULTURE AND LIVESTOCK territories, Municipalities associations, Munici- HEALTH CARE UNIFIED SYSTEM palities consortiums, or other Municipalities’ as- sociative forms. Section I Paragraph 1. Each Local Organ shall, within Eradication and Control of Pests and Dis- its jurisdiction, pay full attention to agriculture eases and livestock health, with the participation of or- Art. 26. Strategies and policies aimed at ganized society, through the following activities: promoting health and surveillance shall be eco- I – Establishment of a property register; systemic and decentralized according to types of II - Inventory of animal and plant popula- health problem so as to ensure pest- and disease- tions; free areas, pursuant to international agreements III – Animal and plant movement control; and treaties of which Brazil is a signatory. IV – Register of active health professionals; Paragraph 1. Whenever epidemiologically V – Execution of sanitary education pro- recommended, the eradication of diseases and grams, projects, and activities pertaining to agri- pests shall have priority under the pest- and dis- culture and livestock health and inspection in its ease-free areas strategy. area of operation; Paragraph 2. Should eradication prove un- VI – Establishment of a register of busi- feasible, prevention, control, and sanitary and phytosanitary programs should be adopted with Art. 33. The Ministry of Agriculture, Live- a view to contain the disease or pest so as to en- stock, and Food Supply as the Central and Superi- sure the recognition of the area as a low preva- or Organ shall prepare contingency, control, and lence area or for the purpose of establishing a emergency plans to address diseases and pests of risk mitigation system. significant impact, and set up National Sanitary Art. 27. For all relevant cases, a contingency and Phytosanitary Emergency Groups. or emergency plan shall be adopted, consistently Paragraph 1. Contingency, control, and with the role of each system’s Organ. emergency plans to address diseases and pests of Art. 28. National or regional prevention, significant impact shall be preventively prepared control, and eradication campaigns must be con- and shall be a priority for all three Organs. sistent with the objective of ensuring the recogni- Paragraph 2. The Ministry of Agriculture, tion of the status of the area, district, zone, or Livestock, and Food Supply as the Central and Su- locality as free of or with low prevalence of pest perior Organ shall coordinate the National Sani- or disease. tary and Phytosanitary Emergency Groups and Art. 29. The Ministry of Agriculture, Live- define the norms for their makeup and function- stock, and Food Supply as the Central and Supe- ing as well as for their qualification and training rior Organ shall establish and keep current the programs, hierarchy, and specific attributions. sanitary and phytosanitary requirements pertain- Paragraph 3. The National Sanitary and ing to the national and international movement Phytosanitary Emergency Groups shall be pref- of animals and plants and of parts, products, and erentially set up by type of sanitary or phyto- subproducts thereof, as well as residues of eco- sanitary problem. nomic value, biologic organisms, and other regu- Paragraph 4. For the functioning of the Na- lated products and items susceptible of serving tional Sanitary and Phytosanitary Emergency as pest or disease substratum, culture medium, Groups, the Ministry of Agriculture, Livestock, vector, or dissemination vehicle. and Food Supply as the Central and Superior Or- Art. 30. The Intermediary and Local Organs gan shall ensure that they will have a minimum shall introduce a warnings and communication of personnel, ongoing training, and mobility con- system for notification of direct or indirect risks ditions so that they can carry out control actions to animal and plant health and for the exchange in case of sanitary or phytosanitary emergencies. of information that may facilitate prompt and Paragraph 5. The National Sanitary and Phy- 24 proper risk assessment and management by the tosanitary Emergency Groups may be assisted members of the Agriculture and Livestock Health by specialized technical teams as defined by the Care Unified System. Ministry of Agriculture, Livestock, and Food Sup- Art. 31. The Ministry of Agriculture, Live- ply as the Central and Superior Organ. stock, and Food Supply as the Central and Supe- Art. 34. The Intermediate Organs shall set rior Organ shall establish mechanisms to permit up and coordinate State or Regional Sanitary and the participation of consortiums of public and Phytosanitary Emergency Groups. private entities, institutes and funds in the imple- Sole Paragraph. To function, the State or mentation of common sanitary or phytosanitary Regional Sanitary and Phytosanitary Emergency policies, so as to ensure in turn greater partici- Groups must be recognized by the Ministry of Ag- pation of microregions in the regional, national, riculture, Livestock, and Food Supply as the Cen- and international markets. tral and Superior Organ. Art. 32. The Agriculture and Livestock Health Art. 35. The National, State, or Regional San- Care Unified System’s three Organs shall establish itary and Phytosanitary Emergency Groups shall mechanisms for the mobilization, coordination, act as operative bodies and assist the competent and organization of local communities with a authorities in their activities, with the support of view to the formulation, implementation, and the Ministry of Agriculture, Livestock, and Food evaluation of sanitary and phytosanitary policies. Supply, and operate as a task force. Paragraph 1. The National, State, or Regional IV – Preparation of contingency, control, and Sanitary and Phytosanitary Emergency Groups emergency plans pertaining to diseases of signifi- shall begin their field operations with the dec- cant impact, defining the administrative authori- laration of a sanitary or phytosanitary state of ties that will intervene, their respective powers alert or emergency as prescribed by the Ministry and responsibilities, as well as the channels of Agriculture, Livestock, and Food Supply as the and procedures for the exchange of information Central and Superior Organ. among the different interveners; Paragraph 2. The National, State, or Regional V – Planning, coordination, and implemen- Sanitary and Phytosanitary Emergency Groups tation of the zoosanitary information system and shall remain permanently prepared and on call, pertinent databank to facilitate the coordination independently from the declaration of emergen- of activities, the exchange of information, and the cies; and shall undertake the recommended pre- preparation and execution of common projects; ventive and corrective measures to contain sani- VI – Planning, coordination, and undertak- tary or phytosanitary events. ing of epidemiologic studies of diseases of inter- Art. 36. The National, State, or Regional est to animal health; Sanitary and Phytosanitary Emergency Groups’ VII – Undertaking of studies and analyses of training and qualification shall be coordinated zoosanitary data and pertinent epidemiologic re- by the Ministry of Agriculture, Livestock, and search to support planning, evaluation, and con- Food Supply as the Central and Superior Organ, trol activities related to sanitary programs and in accordance with the contingency, control, and to strategies for the formulation of the national emergency plans. animal health policy; VIII – Programming, coordination, and ex- Section II ecution of the inspection of the movement of Animal Health animals, veterinary products, animal reproduc- Art. 37. The Agriculture and Livestock Health tion materials, animal feed products, animal Care Unified System shall maintain an animal products, subproducts, and byproducts, as well health promotion service charged also with the as enforcing the sanitary requirements pertain- prevention, control, and eradication of diseases ing to imports and exports; susceptible of harming animal productivity, the IX – Planning, coordination, and execution economy, and agriculture and livestock healthi- of actions related to animal quarantine and per- 25 ness, and shall carry out the following activities tinent quarantine facilities; consistently with the attributions of each Organ X – Planning, coordination, and execution of of the System and with current legislation: actions related to expositions, fairs, auctions, and I –Risk evaluation and control of the move- other animal conglomerations; ment of animals, their products, subproducts, XI – Establishment of control procedures, in- and residues and of any other products or goods cluding audits, for all Agriculture and Livestock likely to serve as disease substratum, culture me- Health Care Unified System Organs, to help ani- dium, vector, or vehicle; mal health management, oversight of activities, II – Establishment of policies, norms, and and planning review; guidelines for disease prevention, control, and XII – Designation and qualification, in con- eradication programs for the purpose of estab- junction with the international agriculture and lishing a free or controlled area; livestock surveillance system, of specific points III – Programming, coordination, and exe- for the entry into the Brazilian territory of im- cution of zoosanitary surveillance actions, with ported animals and products requiring prior no- particular attention to the definition of sanitary tification, taking into account the associated risk, requirements pertaining to the movement of access to control and storage facilities, appropri- animals and of animal products, subproducts, ate quarantine facilities, and the existence of a and byproducts; support laboratory; XIII – Coordination with the network of ac- IV – Preparation of contingency, control, credited, official, and authorized laboratories and emergency plans pertaining to pests of great that carry out activities related to animal health, impact, defining the administrative authorities with a view to enhancing the quality and unifor- that will intervene, their respective powers and mity of results; and responsibilities, as well as the channels and pro- XIV – Coordination of the zoosanitary warn- cedures for the exchange of information among ing system for the notification of risks to animal the different interveners; health and for information to facilitate prompt V – Planning, coordination, and implemen- and proper risk management actions. tation of the phytosanitary information system Sole Paragraph. The importation of animals, and related databank to facilitate the coordina- their products, byproducts, subproducts, and tion of activities, the exchange of information, residues of economic value, animal reproduction and the preparation and execution of common material, and animal organs, tissues, and cells projects; must abide by the principles defined through risk VI – Establishment of phytosanitary require- analysis and the procedures prescribed the Min- ments for authorizing the importation and ex- istry of Agriculture, Livestock, and Food Supply as portation of plants, their products and subprod- Central and Superior Organ. ucts, and of any other items subject to regulation, for commercial, scientific, cultural, or diplomatic Section III purposes; Plant Health VII – Undertaking of studies and analyses of Art. 38. The Agriculture and Livestock Health phytosanitary data and pertinent phytosanitary Care Unified System shall maintain a plant health research to support planning, evaluation, and promotion service charged also with the preven- control activities related to phytosanitary pro- tion, control, and eradication of pests capable of grams and to strategies for the formulation of the harming plant productivity, the economy, and national plant health policy; agriculture and livestock healthiness, and shall VIII – Programming, coordination, and ex- carry out the following activities consistently with ecution of the inspection of the movement of the attributions of each Organ of the System and plants, organic products, plant propagation re- with current legislation: production materials, biologic organisms and I –Risk evaluation and control of the move- any other products, inputs, or goods susceptible 26 ment of plants, their products, subproducts, and of serving as pest substratum, culture medium, residues, organic material and biologic organ- vector, or vehicle, as well as enforcing the phyto- isms, inputs, and of any other products or goods sanitary requirements pertaining to imports and likely to serve as pest substratum, culture medi- exports; um, vector, or vehicle; IX – Planning, coordination, and execution II – Establishment of policies, norms, and of actions related to plant quarantine and perti- guidelines for pest prevention, control, and erad- nent quarantine facilities; ication programs for the purpose of establishing X – Establishment of control procedures, in- a free area or controlled area; cluding audits, for all Agriculture and Livestock III – Programming, coordination, and execu- Health Care Unified System Organs, to help plant tion of phytosanitary surveillance actions, with health management, oversight of activities, and particular attention to the definition of sanitary planning review; requirements pertaining to the movement of XI – Designation and qualification, in con- plants and of plant products, subproducts, and junction with the international agriculture and byproducts, residues, organic material, biologic livestock surveillance system, of specific points organisms, and any products, inputs and goods for the entry into the Brazilian territory of im- susceptible of serving as culture medium, vector, ported plants and products requiring prior noti- or vehicle of pests; fication, taking into account the associated risk, access to control and storage facilities, appropri- Paragraph 3. The Three Organs may sup- ate quarantine facilities, and the existence of a port sanitary education activities carried out support laboratory; by public and private services, institutions, and XII – Coordination with the network of ac- organizations. credited, official, and authorized laboratories Art. 40. The Ministry of Agriculture, Live- that carry out activities related to plant health, stock, and Food Supply as the Central and Su- with a view to enhancing the quality and unifor- perior Organ shall continuously develop plans, mity of analysis results; programs, and actions aimed at sanitary educa- XIII – Regulation of the criteria and guide- tion in agriculture and livestock health and in- lines for the provision of phytosanitary and quar- spection, in coordination with the other Organs antine services by accredited enterprises, collabo- and with the Brazilian Agriculture and Livestock rating centers, and quarantine stations, pursuant Products and Inputs Inspection Systems. to the pertinent legislation; Paragraph 1. The Ministry of Agriculture, XIV – Coordination of the phytosanitary Livestock, and Food Supply as the Central and Su- warnings system for the notification of risks to perior Organ shall establish, regulate, coordinate, plant health and for information to facilitate and periodically evaluate a National Program for prompt and proper risk management actions. Sanitary Education in Agriculture and Livestock Sole Paragraph. The importation of plants, Health and Inspection. their products, byproducts, subproducts, and Paragraph 2. The National Program shall residues of economic value, and of organic, abide by the following guidelines, among others: biologic, and plant propagation material, must I – Promotion of the understanding and abide by the principles defined through risk enforcement of the agriculture and livestock analysis and procedures prescribed the Minis- health and inspection legislation; try of Agriculture, Livestock, and Food Supply as II – Promotion of sanitary education courses; Central and Superior Organ. III – Training of multipliers; IV – Promotion of the exchange of experi- Section IV ences; and Sanitary Education V – Utilization of the means of communication Art. 39. Sanitary education is a strategic as an information and educational instrument. activity and an agriculture and livestock health Art. 41. The Ministry of Agriculture, Live- 27 and inspection tool under the Agriculture and stock, and Food Supply as the Central and Superi- Livestock Health Care Unified System for ensur- or Organ shall support actions geared to sanitary ing the involvement of the participants in the education in agriculture and livestock health and agricultural and livestock production chain and inspection carried out by public and private seg- of society in general, for the achievement of the ments of the agricultural and livestock produc- objectives hereunder. tion chain and by society in general, as well as by Paragraph 1. For the purposes of these Reg- teaching and research institutions, provided such ulations, sanitary education in agriculture and actions are consistent with the National Program livestock health and inspection is understood for Sanitary Education in Agriculture and Live- as the active, ongoing process of utilization of stock Health and Inspection. means, methods, and techniques capable of educating the target public and of developing a Section V critical consciousness. Laboratory Management Paragraph 2. The Agriculture and Livestock Art. 42. The competent authorities of each Health Care Unified System’s Three Organs shall Organ of the Agriculture and Livestock Health have an appropriate structure for sanitary educa- Care Unified System shall designate the accredit- tion actions in regard to agriculture and livestock ed laboratories for the analysis of official control health and inspection. samples, as prescribed by the Ministry of Agricul- ture, Livestock, and Food Supply as the Central procedure to verify compliance with the criteria and Superior Organ. established by said Organ with a view to formally Paragraph 1. The National Agriculture and recognize and accept said laboratory’s analysis Livestock Laboratories are the Ministry of Ag- competence. riculture, Livestock, and Food Supply’s official Paragraph 8. The Intermediate and Local laboratories. Organs may enter into technical cooperation Paragraph 2. The National Agriculture and agreements with reference laboratories in other Livestock Laboratories and accredited public and States. private laboratories make up the Agriculture and Art. 43. In the lack of a laboratory with the Livestock Health Care Unified System’s National appropriate biosecurity level or with prior autho- Network of Agriculture and Livestock Laborato- rization from the Ministry of Agriculture, Live- ries, which is coordinated by the Ministry of Agri- stock, and Food Supply as Central and Superior culture, Livestock, and Food Supply as the Central Organ, the manipulation of any high-risk patho- and Superior Organ. genic organism is hereby prohibited. Paragraph 3. The National Agriculture and Livestock Laboratories shall be organized Section VI into a network, on a hierarchic and regional Movement of Animals, Plants and of oth- basis, and their structure shall be grounded on er Agricultural and Livestock Items the following: Art. 44. The inspection of the domestic and I – The level of complexity of their labora- international movement, by whatever means, of tory facilities; animals and plants, their products and subprod- II – The epidemiologic, sanitary, demo- ucts or any other of their byproducts, as well as graphic, and geographic criteria whereby their of agricultural equipment and implements shall territorial base is defined; and be obligatory for the evaluation of their sanitary III – The activities carried out in their respec- and phytosanitary conditions and verification of tive jurisdictions. their mandatory transit documentation. Paragraph 4. The accreditation of laborato- Paragraph 1. Inspection and sanitary agri- ries shall be according to the demand for analy- culture and livestock control of domestic and ses and tests, and groups of analyses or specific international movement of animals, plants, and specimens, pursuant to the criteria defined by inputs – including animal feed –, and of animal 28 the Ministry of Agriculture, Livestock, and Food and plant products, as well as of agricultural Supply as the Central and Superior Organ. equipment and implements, as required here- Paragraph 5. The competent authority at under, shall follow uniform procedures at all the Agriculture and Livestock Health Care Uni- Agriculture and Livestock Health Care Unified fied System’s Three Organs that is responsible for System’s Organs. accrediting laboratories may at any time cancel Paragraph 2. The authorities responsible their accreditation, should they fail to abide by for domestic and international transport by air, the terms of the accreditation system. international and coastal navigation, railways, Paragraph 6. A laboratory, whether public waterways, and highways shall ensure the access or private, accredited by one of Agriculture and of sanitary agriculture and livestock inspection Livestock Health Care Unified System’s Three Or- teams to passenger departure and arrival areas gans may be designated as a reference laboratory and to cargo loading and unloading facilities. in one or more than one area, provided it meets Paragraph 3. The Ministry of Agriculture, the pertinent requirements. Livestock, and Food Supply as Central and Su- Paragraph 7. In designating a laboratory perior Organ shall establish the requisite norms as a reference laboratory in one or more than for and coordinate the control of domestic and one area to operate within its jurisdiction, an international movement, by whatever means, of Intermediate Organ shall follow a documented animals and plants, their products and subproducts, or any other of their byproducts. III – History of noncompliance in movement Paragraph 4. The Agriculture and Livestock inspection; Health Care Unified System’s Intermediate- Or IV – Definition of the geographic area in- gans shall undertake the agriculture and live- cluded in the program, to which the risk classifi- stock control of interstate movement, pursuant cation or grading applies; to the norms established by the Ministry of Ag- V – Evaluation of the zoosanitary or phyto- riculture, Livestock, and Food Supply as Central sanitary conditions in geographic areas and their and Superior Organ. borders to be classified or graded; Paragraph 5. The Agriculture and Livestock VI – Structure, implementation, and perfor- Health Care Unified System’s Intermediate Organs mance of pest and disease prevention, eradica- shall regulated and coordinate the agriculture and tion, and control programs; livestock inspection of interstate and intra-munic- VII – Organization of the agriculture and ipality movement pursuant to the norms estab- livestock surveillance system; lished by the Ministry of Agriculture, Livestock, VIII – Conditions and effectiveness of animal and Food Supply as Central and Superior Organ. and plant movement inspection; and Paragraph 6. The Agriculture and Livestock IX – Degree of coordination of institution- Health Care Unified System’s Local Organs shall al support structures, including the laboratory undertake the agriculture and livestock inspec- network. tion in their area of operation. Art. 47. The planning of the actions and the Paragraph 7. The Agriculture and Livestock application of sanitary and phytosanitary mea- Health Care Unified System’s Local Organs shall sures pertaining to each disease or pest, and the regulate and coordinate the movement within definition of the norms applicable to the control their municipality, pursuant to norms estab- of the movement of plants, animals, their prod- lished by the Ministry of Agriculture, Livestock, ucts, or of any other products or goods shall be and Food Supply as Central and Superior Organ. based on the classification or grading risk estab- Art. 45. Inspection of the domestic and lished by the Ministry of Agriculture, Livestock, international movement shall include, among and Food Supply as Central and Superior Organ. other measures, the requirement of an official Art. 48. At its discretion, the Ministry of Ag- agriculture and livestock health document issued riculture, Livestock, and Food Supply as Central by the pertinent service, stating their origin, des- and Superior Organ shall identify the movement 29 tination, and purpose, in addition to compliance routes and the specific entry and exit points of with other legal requirements. plants, animals, basic products, and other regulated items susceptible of acting as vectors or Section VII vehicles for the dissemination or dispersion of a Interstate Animal and Plant Movement given pest or disease. Surveillance Paragraph 1. The Intermediate Organs Art. 46. The technical criteria for the classifi- shall install stationary or mobile interstate or cation and grading of the risks of dissemination interregional sanitary and phytosanitary in- and establishment of regulated pests and diseas- spection checkpoints for movement inspection, es by States or geographical regions, which will including, among other measures, intercepting guide interstate movement inspection, shall be mechanisms and the exclusion of and diseases defined by the Ministry of Agriculture, Livestock, and pests, and the destruction of apprehended and Food Supply as Central and Superior Organ, material, in close cooperation with other agen- based on the following: cies as necessary. I – Specific epidemiologic characteristics of Paragraph 2. In case of identification of the pests and diseases in question; pests, diseases, or of vectors or vehicles of II – History of occurrences pest or disease pests or diseases with a high dissemination foci; potential, the infested material shall be immediately sent to destruction or eliminated I – Risks associated with animals, plants, in- pursuant to a specific norm. puts – including animal feed –, as well as animal Paragraph 3. The Organs responsible for and plant products; movement control in their coverage area shall II – Antecedents pertaining to compliance identify the location and facilities destined for with requirements applicable to the product in oversight, inspection, disinfection, disinfestation, question; and sacrifice and destruction, or elimination of ap- III – Producers’ control of animals, plants, in- prehended material, and shall notify the Ministry puts – including animal feed –, as well as animal of Agriculture, Livestock, and Food Supply as Cen- and plant products. tral and Superior Organ accordingly. Paragraph 3. Samples taken for inspection Art. 49. As they undertake animal and plant of agriculture and livestock movement shall be movement control, the competent Intermediate handled in such a way as to preserve their validity and Local Organs authorities shall verify compli- for analysis. ance with the obligations established hereunder Art. 51. The Ministry of Agriculture, Live- and in other pertinent normative acts. stock, and Food Supply as Central and Superior Paragraph 1. The competent Intermediate Organ shall establish and publicize a list of ag- Organ authority shall plan its work and that of ricultural and livestock products that present the Local Organs on the basis of multiyear plans risks associated with pests and diseases and that established in accordance with these Regulations require control and prior movement notification and of the risk classification and grading. between the origin and the destination Organs. Paragraph 2. Controls shall cover all aspects Sole Paragraph. The Organs responsible contemplated by the sanitary legislation pertain- for managing agriculture and livestock sanitary ing to animals, plants, and inputs – including ani- roadblocks shall provide minimum conditions mal feed –, as well as animal and plant products. for the carrying out of agriculture and livestock Paragraph 3. Controls shall be undertaken surveillance connected with interstate, intermu- on all movement routes of plants, animals, their nicipal, and intra-municipality movements. products and any other products, goods, agricul- Art. 52. Should there be signs of nonconfor- tural equipment and implements likely to act as mity with the legislation or doubts as to the iden- pest or disease vectors or dissemination vehicles. tity or destination of products, cargo, or shipment, Paragraph 4. Civil servants at Intermediate or as to the consistency of the products, cargo, or 30 Organs, meeting the requirements under Para- shipment with the certified guarantees, the com- graph 6 of Art. 9 hereunder, shall be competent petent authority at the agriculture and livestock authorities to inspect the movement of plants, sanitary checkpoints may hold the shipment or animals, their products or any other products or lot until such signs or doubts are cleared away. goods, or agricultural equipment or implements Paragraph 1. The competent authority shall of- likely to act as pest or disease vectors or dissemi- ficially hold the transported animals, plants, inputs – nation vehicles as they move between States. including animal feed –, as well as animal and plant Art. 50. Official agriculture and livestock products that do not meet the legal requirements. sanitary controls shall include, at the competent Paragraph 2. The competent authority shall of- authority’s discretion, documental, origin, and ficially notify those responsible for the cargo of the physical control, pursuant to the pertinent norm detected nonconformity, which may be appealed set by the Ministry of Agriculture, Livestock, and in the manner established under a specific norm. Food Supply as Central and Superior Organ. Paragraph 3. At its discretion, the competent Paragraph 1. The frequency and nature of authority shall adopt the following measures: controls shall be set forth in specific norms issued I – It shall order that the animals, plants, inputs by the Three Organs. – including animal feed –, as well as animal and Paragraph 2. The frequency of physical con- plant products be subjected to special treatment or trols shall depend on the following: to quarantine, or returned, sanitary slaughtered, or sent to sacrifice and destruction; or imals, plants, inputs – including animal feed –, II – It shall destine the animals, plants, inputs as well as animal and plant products, and pack- – including animal feed –, as well as animal and aging and wood crates going through customs plant products for purposes other than their origi- or exported by Brazil are under the sole respon- nal purpose, depending on their associated risk. sibility of the Ministry of Agriculture, Livestock, Paragraph 4. In the case of agricultural and Food Supply. equipment and implements capable of dissemi- Paragraph 1. The Ministry of Agriculture, nating diseases and pests, the competent author- Livestock, and Food Supply shall coordinate and ity shall condition their clearance to their disin- carry out the activities called for under the inter- fection or disinfestation. national agriculture and livestock surveillance Paragraph 5. Should nonconformities be de- system. tected, the competent authority shall notify the Paragraph 2. The Ministry of Agriculture, other Organs involved and provide the informa- Livestock, and Food Supply shall set up a man- tion required under specific norms issued by the aging committee for the international agriculture Ministry of Agriculture, Livestock, and Food Sup- and livestock surveillance system at international ply as Central and Superior Organ. airports, regular ports, border checkpoints, and Paragraph 6. The competent authority shall special customs, which will serve as consultative ensure that special treatment or quarantine be ap- bodies to the competent authorities. plied in accordance with the conditions established Paragraph 3. The Federal Agriculture and hereunder and with the applicable specific norms. Livestock Inspectors are the competent authori- Paragraph 7. The maximum period for which ties to undertake the agriculture and livestock cargoes or lots may be held for agriculture and sanitary inspection of imports, exports, as well as livestock sanitary control shall be fifteen days. of customs procedures pertaining to the move- Paragraph 8. The maximum period referred ment of animals, plants, inputs – including ani- to in the preceding Paragraph 7 may be extended mal feed –, and animal and plant products. at the competent authority’s discretion in cases Paragraph 4. The general norms regarding specified under specific norms. international agriculture and livestock surveil- Paragraph 9. If at the expiration of the fif- lance contemplated hereunder and in specific teen-day deadline the shipment has not been legislation shall apply to official control of im- reshipped, save for justified delay, the shipment ported and exported animals, plants, inputs – 31 shall be returned, sanitary slaughtered, or sent to including animal feed –, as well as animal and sacrifice and destruction. plant products. Art. 53. The competent authority shall apprise Paragraph 5. Official controls shall encom- the Ministry of Agriculture, Livestock, and Food Sup- pass all aspects of agriculture and livestock sani- ply as Central and Superior Organ of its decisions, tary legislation pertaining to animals, plants, in- preferably through the official electronic system. puts – including animal feed –, as well as animal Art. 54. Those responsible for contracting car- and plant products. rier services and the carrier of animals, plants, in- Paragraph 6. Official controls shall be un- puts – including animal feed –, as well as animal dertaken on sites designated by the Ministry of and plant products, and agricultural equipment Agriculture, Livestock, and Food Supply, includ- and implements shall bear the expenses incurred ing points of entry and exit of goods on national as a result of the competent authorities’ decisions. territory, entrepots, and production facilities, whether subject to customs clearance or destined Section VIII for free zones, special entrepots, special reexpor- International Agricultural Goods and tation units, or other points on the chain of pro- Livestock Movement Surveillance duction and distribution, including reshipment. Art. 55. Agriculture and livestock sanitary Art. 56. The Ministry of Agriculture, Live- surveillance activities pertaining to imported an- stock, and Food Supply as Central and Superior Organ shall define the primary agriculture and airports, special customs, border checkpoints, and livestock health and inspection zones and es- other qualified points or bonded warehouses as tablish import and export corridors for animals, defined by the Ministry of Agriculture, Livestock, plants, inputs – including animal feed –, as well and Food Supply as Central and Superior Organ. as animal and plant products on the basis of risk Art. 59. Should there be signs of noncon- analysis, sanitary requirements and controls, formity with the legislation or any doubts as to zoosanitary and phytosanitary status, geographic the identity, quality, or destination of products, location, and availability of infrastructure and cargo, or shipment, or as to the consistency of the human resources. imports with the certified guarantees, the com- Art. 57. Agriculture and livestock sanitary petent authority at the international agriculture controls pertaining to the exportation or impor- and livestock surveillance units may hold the tation of animals, plants, inputs – including ani- shipment or lot until such signs or doubts are mal feed –, as well as animal and plant products cleared away. shall include, at the competent authority’s discre- Paragraph 1. The competent authority shall tion, documental, identity, and physical control officially notify those responsible for the cargo of pursuant to the pertinent norm established by the nonconformity detected, which may be sub- the Ministry of Agriculture, Livestock, and Food ject to appeal, pursuant to the established norm. Supply as Central and Superior Organ. Paragraph 2. The competent authority may, Paragraph 1. The frequency and nature of at its discretion and in accordance with the perti- such controls shall be defined by the Ministry of nent legislation: Agriculture, Livestock, and Food Supply as Cen- I – Order the animals, plants, inputs – includ- tral and Superior Organ, and shall depend on the ing animal feed –, as well as animal and plant following: products to be sanitary sacrificed or destroyed, I – The risks associated with the animals, subjected to special or quarantine treatment, re- plants, inputs – including animal feed –, as well turned, or reexported; as animal and plant products; II – Order the animals, plants, inputs – in- II – The controls undertaken by producers or cluding animal feed –, as well as animal and importers; and plant products to be destined for other than the III – The guarantees issued by the exporting original purpose, depending on their associated country’s competent authorities. risk; and 32 Paragraph 2. Samples must be handled in III – Notify the other customs services of such a way as to preserve their validity for analysis. its denial decision and provide information on Paragraph 3. For organizing the official con- the final destination of the imports in question, trols pertaining to international agriculture and in case of detected nonconformity or of denial livestock surveillance, the Ministry of Agriculture, of authorization for the entry of said animals, Livestock, and Food Supply as Central and Superi- plants, inputs – including animal feed –, as well or Organ may require that importers or those re- as animal and plant products. sponsible for the importation of animals, plants, Paragraph 3. At the competent authority’s inputs – including animal feed –, as well as ani- discretion and in accordance with the pertinent mal and plant products provide prior notification legislation, the measures referred to in Paragraph of such imports’ nature and arrival, pursuant to 2, I above, shall be as follows: a specific norm. I – Treatment or processing so that the ani- Art. 58. Those responsible for the admin- mals, plants, inputs – including animal feed –, as istration of customs facilities shall ensure basic well as animal and plant products are made to and proper conditions for the carrying out of in- conform with the requirements of national leg- ternational agriculture and livestock surveillance islation or with the requirements of a reshipping activities and for the operation of the points of exporter country, including decontamination, as entry and exit on the national territory at ports, the case may be, but exclusive of dilution; and II – Processing, through any other appropri- ucts shall bear the expenses incurred as a result ate manner, for purposes other than the original of the competent authorities’ decisions. purpose, except for animal or human consump- Art. 60. The Ministry of Agriculture, Live- tion, provided such processing is allowed under stock, and Food Supply as Central and Superior the pertinent legislation. Organ’s competent agriculture and livestock sur- Paragraph 4. The competent authority veillance authorities and the other customs, pub- shall ensure that the special or quarantine lic, and private services shall work in close coop- treatment is dispensed at official or accredited eration in the organization of the official controls establishments and in conformity with the referred to hereunder. conditions specified hereunder and with ap- Paragraph 1. The customs services shall not proved specific norms. permit the introduction into or the handling in Paragraph 5. The Ministry of Agriculture, primary zones, free zones, or special customs of Livestock, and Food Supply as Central and Su- shipments of animals, plants, inputs – includ- perior Organ’s competent authority shall permit ing animal feed –, as well as animal and plant reexportation, provided that: products without approval of the Ministry of I – The new destination has been approved Agriculture, Livestock, and Food Supply’s com- by the party responsible for the cargo; and petent international agriculture and livestock II – The destination country has been informed surveillance authority. in advance of the motives and circumstances that Paragraph 2. The Ministry of Agriculture, prevented the entry of the animals, plants, inputs Livestock, and Food Supply as Central and – including animal feed –, as well as animal and Superior Organ’s competent authority shall, plant products in question into Brazil. through the documentation stipulated under Paragraph 6. The maximum period for specific, pertinent norms, inform the customs which cargoes or lots may be held for agricul- services and the importers whether the lots ture and livestock sanitary control shall be fif- may or may not be introduced into the na- teen days. tional territory. Paragraph 7. The maximum period referred Paragraph 3. The Ministry of Agriculture, to in the preceding Paragraph 6 may be extended Livestock, and Food Supply’s competent authority at the competent authority’s discretion in cases shall, through the documentation stipulated un- specified under specific norms. der specific, pertinent norms, inform the customs 33 Paragraph 8. If at the expiration of the services and the importers whether the goods fifteen-day deadline the shipment has not been may or may not be admitted into the national reshipped, save for justified delay, the shipment territory before the sample analysis’ results have shall be destroyed. been obtained, unless the imports’ traceability is Paragraph 9. The competent authorities of guaranteed. the Ministry of Agriculture, Livestock, and Food Art. 61. In conformity with these Regula- Supply as Central and Superior Organ shall notify tions, necessary measures shall be taken to en- the customs services of its decisions, preferably sure the uniform execution of the official controls through the computerized system. pertaining to the introduction of animals, plants, Paragraph 10. The Ministry of Agriculture, inputs – including animal feed –, as well as ani- Livestock, and Food Supply as Central and Superi- mal and plant products. or Organ shall take the requisite measures to prevent the introduction of the rejected or refused Section IX cargo into the national territory, as provided for Certifications under the legislation. Art. 62. It is incumbent upon the Three Paragraph 11. Those responsible for the im- Organs of the Agriculture and Livestock Health portation of animals, plants, inputs – including Care Unified System and to the Brazilian Sys- animal feed –, as well as animal and plant prod- tems of Agricultural and Livestock Product and Input Inspection, within their respective III – The qualification of those charged with areas of competence, to introduce, monitor, certification; and manage the procedures for sanitary, phy- IV – The guarantees and the reliability of cer- tosanitary, identity, and quality certification to tification, including electronic certification; guarantee the origin, quality, and identity of V – The procedures for issuing, following-up, certified products and endow the traceability monitoring, canceling, correcting, and replacing process with credibility. certificates; and Paragraph 1.The control processes shall en- VI – The documents that must accompany sure the conditions for identifying and ascertain- the lot, shipment, or cargo after the official con- ing the supplier of the certified material at the trols. products’ origin and destination. Said products Art. 66. Whenever certification is required, shall be identified by codes that permit their the following must be ensured: traceability along the entire production chain as I – That there is relation and guaranteed prescribed by a specific norm. traceability between the certificate and the ship- Paragraph 2. Under the law, it is incum- ment, lot, item, or cargo; bent upon the Federal Agriculture and Live- II – That the information contained in the stock Inspectors to issue the official agriculture certificate is true and accurate; and and livestock certificates required by interna- III – That the specific requirements pertain- tional trade. ing to certification have been met. Art. 63. The Ministry of Agriculture, Live- stock, and Food Supply as Central and Superior Section X Organ shall establish and coordinate databanks Registers and Records pertaining to certification. Art. 67. The Ministry of Agriculture, Live- Sole Paragraph. The sanitary and phytosan- stock, and Food Supply as Central and Superior itary requirements for intermunicipal, interstate, Organ shall, in the form established by it, pro- and international movement of animals, plants, mote the databanks’ coordination and manage- and their products or subproducts, as well as of ment, interconnecting the Agriculture and Live- other products that might serve as substratum, stock Health Care Unified System’s Three Organs culture medium, vector, or vehicle of regulated for the maintenance of a unified record and reg- diseases or pests shall be defined by specific in- ister based on uniform identification. 34 formation norms pertaining to certification. Art. 68. The Ministry of Agriculture, Live- Art. 64. A national register of qualified stock, and Food Supply as Central and Superior technical personnel entitled to issue certificates Organ shall define the procedures pertaining to of sanitary origin, phytosanitary origin, identity, the register of establishments and organizations. and quality, as well plant movement permits and Paragraph 1. The obligatory register shall animal Movement Permits defined by the Min- be established by the official services in the area istry of Agriculture, Livestock, and Food Supply of competence of the Agriculture and Livestock as Central and Superior Organ and the pertinent Health Care Unified System in the manner de- legislation shall be established. fined by the Agriculture and Livestock Health Art. 65. Without prejudice to the general re- Care Unified System. quirements adopted for agriculture and livestock Paragraph 2. The register shall contain in- health and to Brazilian and international norms, dividual identification in the Agriculture and the certification process shall take the following Livestock Health Care Unified System, which will into account: identify the interested parties in all procedures of I – The certificate forms prescribed under their interest. current norms; Paragraph 3. In case there are other official II – The sanitary and phytosanitary require- registers established for other purposes, the in- ments and certification’s legal underpinning; formation and the database they contain shall be preferentially used to complement the Agriculture Paragraph 2. The competent authority shall and Livestock Health Care Unified System’s unified accredit a services provider if requirements un- register and data for the purposes hereunder. der the agricultural and livestock requirements Paragraph 4. The competent authorities of and other legal requirements have been met. the Agriculture and Livestock Health Care Uni- Paragraph 3. It is incumbent upon the com- fied System’s Three Organs shall keep current petent authority to establish whether a services the register of establishments and producers of provider meets the requirements pertaining to animals, plants, and agricultural and livestock in- procedures, personnel, infrastructure, equip- puts – including animal feed –, whether they are ment, technical know-how, as well as other legal individuals or legal entities, enterprises, services requirements as established hereunder and under providers, or organizations. specific sanitary and phytosanitary legislation. Art. 69. The Ministry of Agriculture, Livestock, Art. 71. The competent authority shall, at its and Food Supply as Central and Superior Organ discretion and in the form prescribed by the Min- shall define the procedures to be followed for the istry of Agriculture, Livestock, and Food Supply registration of establishments, organizations, or as Central and Superior Organ, audit and inspect products in accordance with these Regulations. the services provider’s activities. Paragraph 1. The granting of registration Paragraph 1. In case any deficiency or non- with the Agriculture and Livestock Health Care conformity is detected, the competent author- Unified System shall require official inspection ity shall take the corrective measures prescribed and auditing to verify whether legal provisions under a specific norm and may at is discretion and the requirements hereunder have been met. suspend the provision of accredited services until Paragraph 2. The register shall be used sole- said deficiency or nonconformity is corrected by ly for the purpose for which it has been estab- a specified deadline. lished; its transfer to or utilization by other units Paragraph 2. Should deficiencies and non- or establishments is hereby prohibited. conformity persist after the expiration of the Paragraph 3. A registered establishment deadline referred to in the preceding Paragraph is obligated to purchase only material that is 1, procedures for disaccreditation of the enter- in conformity with the requirements of current prise or organization shall be started, while the legislation. right of Health and Inspection shall be assured, Paragraph 4. A registered establishment is without prejudice to the application of the penal- 35 obligated to cooperate and to grant qualified ties established under the pertinent legislation. persons free access to their premises for inspec- Paragraph 3. In case of relapse into noncon- tion, auditing, sample collection, and verification formity or deficiency or of nonconformity and de- of documents. ficiency deemed serious under a specific norm, the competent authority shall suspend accreditation Section XI forthright and start disaccreditation procedures. Accreditation of Providers of Technical Art. 72. The competent authorities shall and Operating Services maintain current registers of accredited services Art. 70. The Ministry of Agriculture, Live- providers, preferably on an electronic medium, stock, and Food Supply as Central and Superior and make said registers available to all Agriculture Organ shall define the procedures to be followed and Livestock Health Care Unified System Organs for accreditation of enterprises or organizations and to the general public as may be appropriate. interested in providing technical or operating ser- Art. 73. The following shall be incumbent vices in accordance with current legislation. upon services providers: Paragraph 1. Whenever it receives an accredi- I – To meet the criteria, guidelines, param- tation request, the competent authority shall visit eters, and specifications pertaining to services, the premises and issue an inspection report and materials and products, physical plant, equip- other pertinent reports in the prescribed form. ment components, and modes of applying treatment and procedures, as well to safety measures tral and Superior Organ shall permit qualified under specific norms; private professionals to issue documents and II – Whenever requested to do so, to make render services, in accordance with other specific available to the Three Organs the accreditation legislation. supporting documents, a list of products and equipment utilized, and a history of activi- Section XIII ties carried out and services provided, for the Compliance with International Commit- purpose of agriculture and livestock sanitary ments inspection; Art. 76. The Agriculture and Livestock Health III – To grant the competent authority access Care Unified System’s Three Organs shall be re- to the facilities, so that the competent authority sponsible for compliance with commitments may visit them and issue an inspection report and and obligations under international agreements other pertinent reports as prescribed by the regu- signed by Brazil in connection with agriculture lations, whenever accreditation is applied for, or and livestock health activities. at any time; Paragraph 1. The Ministry of Agriculture, IV – To inform the pertinent Organ of any Livestock, and Food Supply as Central and Su- change in the information submitted for accredi- perior Organ shall coordinate and follow the tation, for analysis with a view to approval and implementation of decisions of interest to the authorization; national agriculture and livestock sector issued V – To keep for at least five years the records by international organizations or stemming from and information on procedures and services ren- agreements with foreign governments. dered and provided; and Paragraph 2. Without prejudice to its rights VI – To guarantee supervision by a techni- and obligations at international forums, the Min- cal staff member pursuant to current agriculture istry of Agriculture, Livestock, and Food Supply as and livestock sanitary legislation. Central and Superior Organ shall: Art. 74. Under a specific norm, the Minis- I – Contribute to the consistent formula- try of Agriculture, Livestock, and Food Supply as tion of international technical norms pertain- Central and Superior Organ shall define accredi- ing to agricultural and livestock products and tation procedures, services whose accreditation animal feeds, as well as of sanitary and phyto- shall be obligatorily homologated, and specific sanitary norms; 36 homologation rules, in accordance with the per- II – Promote the coordination of the work tinent legislation. on norms proposed by international organizations in connection with agriculture and livestock Section XII Health and Inspection, whenever justified; Qualification and Recognition of Profes- III – Contribute, whenever relevant and ap- sionals propriate, to the preparation of agreements re- Art. 75. Agriculture and Livestock Health garding the recognizing of the equivalence of Care Unified System’s Three Organs may qualify specific measures related to animal and plant professionals to render services and issue docu- products and to animal feed; ments pursuant to current legislation in the IV – Pay special attention to the specific de- manner defined by the Ministry of Agriculture, velopment, financial, and commercial needs of Livestock, and Food Supply as Central and Su- the States so as to ensure that international norms perior Organ. will not raise obstacles to their exports; and Paragraph 1. It shall be incumbent upon the V – Promote consistency between interna- Three Organs to promote and inspect the activi- tional technical norms and the legislation on ag- ties carried out by professionals. riculture and livestock health care, while at the Paragraph 2. In special cases, the Ministry of same time ensuring that the level of protection Agriculture, Livestock, and Food Supply as Cen- will not be reduced. Section XIV further training; and Personnel Training IV – Be able to work in cooperation with a Art. 77. Agriculture and Livestock Health multidisciplinary team. Care Unified System’s Three Organs shall be responsible for the training of their professional CHAPTER IV staff. Paragraph 1. Training activities shall be uti- METHODOLOGY AND SPECIAL lized to develop a harmonious approach to of- PROCEDURES ficial controls at Agriculture and Livestock Health Care Unified System’s Three Organs. Section I Paragraph 2. The qualification and train- Risk Analysis ing program shall address the following topics Art. 80. Risk analysis is the basic method among others: used in defining procedures pertaining to agri- I – National and international legislation on culture and livestock health care. agriculture and livestock health; Paragraph 1. Risk analyses shall use the ref- II – Control methods and techniques, such erences and internationally harmonized concepts as audit systems conceived by operators, for approved under agreements signed by Brazil. complying with agriculture and livestock health Paragraph 2. To achieve the overall objec- legislation; tive of ensuring a high level of animal and plant III – Methods and techniques of production health protection and the safety of animal and and marketing of inputs, including animal feed, plant products, sanitary and phytosanitary mea- as well as animal and plant products; sures shall be based on risk analysis, unless this is IV – Pedagogical and communications inappropriate under the circumstances or in view means, methods, and techniques for the work of of the measure’s nature. sanitary educators with participants of the pro- Paragraph 3. Risk analyses shall take into duction chain and with society in general; and consideration the available scientific information, V – Other specific issues of the competence the pertinent production processes and methods, of each Organ, to be defined by the Ministry of the pertinent testing, sampling, and inspection Agriculture, Livestock, and Food Supply as Cen- methods, the prevalence of specific pests or dis- tral and Superior Organ. eases, the existence of areas and localities free of 37 Paragraph 3. Training activities may be open pests or diseases, the environmental and ecologic to participants from other countries. conditions, and the quarantine regimes. Art. 78. The Ministry of Agriculture, Live- Paragraph 4. The choice of a measure to be stock, and Food Supply as Central and Superior applied to achieve the adequate level of sanitary Organ shall propose the training policy in consul- and phytosanitary protection should consider the tation with the Intermediate and Local Organs. potential damage to animal and plant health, the Art. 79. The competent authorities of the economic losses resulting from the introduction, Agriculture and Livestock Health Care Unified Sys- establishment, and dissemination of a given pest tem’s Three Organs shall ensure that their official or disease, the costs of control and eradication control personnel shall: on the affected territory, and the cost/benefit of I – Have the professional training required alternative approaches to limiting risks. for agriculture and livestock health activities; Art. 81. The competent authorities of the II – Receive, in their respective area of work, Agriculture and Livestock Health Care Unified appropriate training and mandates to discharge System’s Three Organs shall establish procedures the functions of their competence, with indepen- for the identification of risks in the areas of their dence and impartiality; competence. III – Keep abreast of developments in their Art. 82. Whenever an authority suspects that area of competence and, if necessary, receive there is a sanitary or phytosanitary risk, it shall request additional information from the other ation the size and nature of his operation; Agriculture and Livestock Health Care Unified II – Make sure that all documents describing System’s Organs, which shall promptly provide all the processes followed are kept current; and pertinent information in their possession. III – Keep any other documents and records Art. 83. The necessary corrective measures to for the period determined by the Ministry of Ag- determine the adequate level of sanitary and phy- riculture, Livestock, and Food Supply as Central tosanitary protection for a locality, Municipality, re- and Superior Organ. gion, or State in connection with an identified risk Paragraph 2. Special conditions shall be de- shall be consistent with the objective of reducing to vised for small producers of animals and plants, a minimum the negative effects on the Agriculture requiring the use of processes mentioned in the and Livestock Health Care Unified System and on guidelines for the application of HACCP principles trade among the involved localities and areas. or principles of equivalent systems. Paragraph 1. Should scientific evidence be Paragraph 3. Conditions should specify the insufficient for risk analysis, protection sanitary period during which small producers must keep and phytosanitary measures may be provisionally documents and records. adopted at the authority’s discretion on the basis Paragraph 4. Actions, programs, and proj- of available information, including information ects implemented with the objective of valorizing originating in reference international organiza- control activities related to the HACCP system shall tions, as well as of sanitary and phytosanitary be recognized under the Agriculture and Livestock measures adopted by other countries. Health Care Unified System pursuant to specific Paragraph 2. Risk analyses shall be necessary acts issued by the Ministry of Agriculture, Livestock, for the authorization of the importation of ani- and Food Supply as Central and Superior Organ. mals, plants, and products thereof whenever this is warranted by the sanitary and phytosanitary con- CHAPTER V ditions in the country or origin or of its neighbor countries, or in case of noncompliance with the AGRICULTURE AND LIVESTOCK HEALTH established sanitary or phytosanitary standards. AND INSPECTION Paragraph 3. The Ministry of Agriculture, COMPLEMENTARY NORMS Livestock, and Food Supply as Central and Su- perior Organ shall analyze the Brazilian regions, Section I 38 formulate diagnostics, and propose lines of action Commitment toward Consumers and Pro- based on risk analysis studies, as a strategy for de- ducers veloping local, regional, or national agribusiness. Art. 85. The national and State complementary agriculture and livestock Health and Inspec- Section II tion norms are drafted according to the guidelines Hazard Analysis and Critical Control hereunder and seek to protect the interests of con- Points (HACCP) sumers, agricultural and livestock production, and Art. 84. Producers of animals, plants, ag- producers in connection with raw materials’ quality, ricultural and livestock inputs – including ani- inputs, fraud, product alteration, and practices sus- mal feed –, and animal and plant products shall ceptible of leading consumers into error, keeping in abide by the Hazard Analysis and Critical Control view the guarantee of animal and plant healthiness Point principles pursuant to specific norms. and the safety of animal and plant products. Paragraph 1. In accordance with specific Sole Paragraph. The complementary norms norms, a producer of animals, plants, agricul- referred to in the preceding shall define and tural and livestock inputs shall: stress the producer’s responsibility for placing I – Provide the competent authority with safe products and services on the market, con- proof of compliance with established require- trolling production, and observing the critical ments in the requisite form, taking into consider- control points of every approved process. Section II III – Detection limit; Drafting of Complementary Norms of IV – Determination limit; Good Practices V – Precision; Art. 86. The Agriculture and Livestock Health VI – Recovery; Care Unified System’s Three Organs shall draft VII – Selectivity; complementary norms of good practices for agri- VIII – Sensitivity; culture and livestock health, including operating IX – Linearity; hygiene standard procedures to permit the appli- X – Measurements uncertainty; and cation of pest and disease risk analysis principles XI – Other criteria that may be chosen as and of hazard analysis and critical control points needed. consistently with these Regulations. Paragraph 1. The results indicating the accu- Paragraph 1. The National Agricultural Pol- racy referred to in item I above should be obtained icy Council shall approve the national and state through trial of groups of products conducted in complementary norms and determine their pe- accordance with nationally or internationally rec- riodical review. ognized protocols and, if performance criteria Paragraph 2. Said review’s purpose is to en- have been established for the analysis methods, sure that the complementary norms continue to accuracy should be based on conformity tests. be objectively applied and to incorporate scien- Paragraph 2. Results of trial of groups of tific and technologic advances. products shall be published or made available Paragraph 3. The national complementary without restriction. norms’ titles and references shall be published Paragraph 3. Analysis methods uniformly and publicized throughout the national territory. applied to several groups of products shall be Paragraph 4. The national complementary preferable to methods applicable only to specific norms of good practices shall be drafted for each products. production chain and with the participation of Paragraph 4. Special norms and guidelines producers and other agents on the chain, and aimed at harmonization shall be established for shall take into consideration pertinent comple- situations in which: mentary norms of good practices of reference I – The analysis methods can be validated international organizations. solely at accredited or reference laboratories; Art. 87. The Intermediate Organs may, at and 39 their discretion and keeping in view specific in- II – The performance criteria for the analysis terests, draft their own complementary norms of methods are abased on conformity tests. good practices, which shall be submitted to the Art. 89. Analysis methods adapted to these Ministry of Agriculture, Livestock, and Food Sup- Regulations shall be conceived pursuant to speci- ply as Central and Superior Organ and to other fications and to nationally and internationally Intermediate Organs for their information. recommended analysis methods.

CHAPTER VI Section II Sampling OPERATIONALIZATION AND CONTROL Art. 90. Sampling and analysis methods used for official controls should comply with ap- Section I plicable Brazilian norms. Laboratory Control Paragraph 1. The analysis methods should Art. 88. Analysis methods should meet the be validated in laboratories in accordance with following criteria: national norms or with internationally recom- I – Accuracy; mended protocols. II – Applicability (matrix and concentration Paragraph 2. In the absence of internation- spectrum); ally recognized national norm or protocol, the Ministry of Agriculture, Livestock, and Food Sup- rent information on the sanitary agriculture and ply as Central and Superior Organ shall approve livestock controls may be requested at the discre- norms or instructions defining appropriate meth- tion of the Ministry of Agriculture, Livestock, and ods for achieving the intended objective. Food Supply as Central and Superior Organ. Paragraph 3. The analysis methods should Art. 94. General audits shall be complement- have the characteristics defined hereunder. ed with specific audits and specific inspections in Art. 91. The competent authorities of the Min- one or more than one specified area. istry of Agriculture, Livestock, and Food Supply as Paragraph 1. Specific audits and inspections Central and Superior Organ shall regulate counter- have the following purposes: proof procedures and establish appropriate proce- I – To assess the implementation of the na- dures to ensure the right of producers of animals, tional multi-year control plan and the enforce- plants, inputs – including animal feed – and animal ment of legislation pertaining to animals, plants, and plant products, whose products are subjected inputs – including animal feed – and animal and to sampling and analysis, to seek the opinion of plant products, and may include, as the case may another accredited expert as prescribed, without be, on-site inspection of official services and fa- prejudice to the competent authorities’ obligation cilities associated with the production chain sub- to take prompt measures in emergencies. jected to the audit. Sole Paragraph. Counterproof procedures II – To assess the Intermediate and Local and second opinions do not apply in case of risks Organs’ operation conditions and their work or- associated with animals, plants, and perishable ganization; agricultural and livestock products. III – To identify, evaluate, and propose con- Art. 92. Samples should be properly collect- tingency or emergency plans geared to relevant, ed, handled, conditioned, identified, and trans- critical, or recurring problems at the Intermedi- ported so as to ensure their validity for analysis. ate and Local Organs; and IV – To investigate emergency situations, Section III emerging problems, resolution of contingency Agriculture and Livestock Health Care plans, or improvements at Intermediate and Lo- Unified System’s Controls cal Organs. Art. 93. The Ministry of Agriculture, Live- Paragraph 2. The Ministry of Agriculture, stock, and Food Supply as Central and Superior Livestock, and Food Supply as Central and Supe- 40 Organ shall perform general and specific audits rior Organ shall prepare a report on the results of in the Intermediate and Local Organs to assess audits in which it participates. the conformity of their controls and activities Paragraph 3. The reports should include, as with national multi-year control plans. the case may be, recommendations to the Inter- Paragraph 1. The Ministry of Agriculture, mediate and Local Organs aimed at enhancing Livestock, and Food Supply as Central and Supe- compliance with the agriculture and livestock rior Organ may designate Intermediate and Local health and inspection legislation. Organ experts, if necessary, to perform or support Paragraph 4. The Ministry of Agriculture, general and specific audits at the other Interme- Livestock, and Food Supply as Central and Supe- diate and Local Organs. rior Organ shall submit to the Intermediate and Paragraph 2. General and specific audits Local Organ’s competent authority the draft re- shall be performed in coordination with and with port, and the competent authority shall submit the cooperation of the competent authorities of its opinion and comments within thirty days. the Intermediate and Local Organs. Paragraph 5. The Intermediate and Local Paragraph 3. General audits shall be regular- Organ’s opinion and comments shall be included ly performed in accordance with the multi-year in the final report, provided they are submitted control plans. by the deadline established in the preceding Paragraph 4. Before general audits, , cur- Paragraph. Paragraph 6. The reports shall be publicized animals, plants, inputs – including animal feed as determined by the Ministry of Agriculture, – and animal and plant products that will be Livestock, and Food Supply as Central and Supe- subjected to official controls at the points of en- rior Organ. try into the national territory, at the authorities’ Art. 95. The Intermediate and Local Organs discretion. shall: Art. 99. The competent authorities of the I – Participate in general and specific audits Ministry of Agriculture, Livestock, and Food Sup- performed by the Ministry of Agriculture, Live- ply as Central and Superior Organ shall under- stock, and Food Supply as Central and Superior take official controls to verify conformity with the Organ; legislation pertaining to importation and expor- II – Perform their own general and specific tation, as specified hereunder. audits; Art. 100. The Ministry of Agriculture, Live- III – Adopt corrective measures pursuant to stock, and Food Supply as Central and Superior the recommendations stemming from the audits; Organ shall define, under specific norms and by IV – Provide all the requisite assistance and country, special controls prior to the exportation all the documentation and any other kind of to Brazil of animals, plants, inputs – including technical support requested by the Ministry of animal feed – and animal and plant products to Agriculture, Livestock, and Food Supply as Cen- ensure that the requirements and other condi- tral and Highest Organ; and tions hereunder are met. V – Grant the auditors of the Ministry of Ag- Paragraph 1. Approval shall be granted re- riculture, Livestock, and Food Supply as Central garding animals, plants, inputs – including ani- and Superior Organ access to all the facilities or mal feed – and animal and plant products from parts thereof as well as to all requested informa- countries that have a sanitary agreement with tion, including information systems, which may Brazil; approval may be granted to one or more be relevant for the audit. than one product. Art. 96. The Ministry of Agriculture, Livestock, Paragraph 2. Should approval be granted and Food Supply as Central and Superior Organ pursuant to the preceding Paragraph, the con- shall at any time assess the sanitary or phytosani- trol of the importation of animals, plants, in- tary conditions or the consistency between the puts – including animal feed – and animal and legislation and the sanitary agriculture and live- plant products will be simplified and expedited 41 stock systems adopted by the Intermediate and in accordance with the associated risk and the Local Organs as pertains the federal agriculture specific rules established by the Ministry of Ag- and livestock healt and inspection legislation. riculture, Livestock, and Food Supply as Central and Superior Organ. Section IV Paragraph 3. Controls prior to exportation Imports and Exports Control undertaken at the country of origin may be effi- Art. 97. Importers of animals, plants, inputs cient, at the competent authority’s discretion, the – including animal feed – and animal and plant undertaking of further official controls may be re- products susceptible of presenting the risk of in- quested to confirm the healthiness and quality of troduction and dissemination of diseases or pests the imported animals, plants, inputs – including are obligated to meet the requirements hereun- animal feed – and animal and plant products. der and comply with the norms established by Paragraph 4. The approval referred to in Para- the Ministry of Agriculture, Livestock, and Food graph 1 above shall be granted, provided that: Supply as Central and Superior Organ. I – The audits or official procedures under- Art. 98. The Ministry of Agriculture, Live- taken on the basis of specifications defined by stock, and Food Supply as Central and Superior the Ministry of Agriculture, Livestock, and Food Organ shall, on the basis of risk analysis, estab- Supply as Central and Superior Organ prove that lish and keep current a list of pests and diseases, the animals, plants, inputs – including animal feed – and animal and plant products exported Art. 102. The Ministry of Agriculture, Livestock, to Brazil meet the requirements hereunder or and Food Supply as Central and Superior Organ equivalent requirements; and shall establish specific norms for the undertaking II – The controls undertaken at the country of importation control pertaining to the following: of origin prior to shipment are deemed suffi- I – Animals and plants without commercial ciently efficient and effective to replace or reduce value, whenever international transportation the documental, identity, and physical control means are used; contemplated hereunder. II – Exemptions or specific conditions appli- Paragraph 5. The approval shall identify cable to certain processing, industrialization, and the competent authority in the country of origin immediate exportation procedures; under whose responsibility the controls prior to III – Animal and plant products for supplying exportation are undertaken. crew and passengers of international means of Paragraph 6. The competent authority or transportation; control organ specified in the approval of the ex- IV – Inputs, including animal feed, and porter country shall be responsible for contacts animal and plant products ordered by mail, with the Ministry of Agriculture, Livestock, and telephone, or the internet, and delivered to the Food Supply as Central and Superior Organ. consumer; Paragraph 7. The competent authority or V – Animal feed and animal and plant prod- control organ in the exporting country shall en- ucts carried by crew and passengers of interna- sure the official certification of the controlled tional means of transportation; shipment before the latter’s entry into the na- VI – Shipments from Brazil that are being re- tional territory. turned by importing countries; and Paragraph 8. The approval shall specify the VI I- Documents that must accompany ship- certificate forms. ments, whenever samples are collected. Paragraph 9. Should the official control of Art. 103. The Ministry of Agriculture, Live- imports subject to the aforementioned proce- stock, and Food Supply as Central and Superior dure detect any noncompliance with these Regu- Organ may at any time evaluate the sanitary con- lations, the authorities of the Ministry of Agricul- dition or the equivalence of the legislation and of ture, Livestock, and Food Supply as Central and the agriculture and livestock sanitary systems of Superior Organ shall broaden inspections and exporter and importer countries with the Brazil- 42 controls, pursuant to the noncompliance’s seri- ian agriculture and livestock health and inspec- ousness, and undertake new risk analysis, and tion legislation. shall immediately notify the exporting countries Paragraph 1. The Ministry of Agriculture, in accordance with the pertinent agriculture and Livestock, and Food Supply as Central and Supe- livestock sanitary agreements. rior Organ may at its discretion designate experts Paragraph 10. Should the noncompliance or specialists for the specific tasks referred to in referred to in Paragraph 9 above persist or should this article’s heading. the noncompliance jeopardize the objectives Paragraph 2. Evaluations should address hereunder, including agriculture and livestock the following items, among others: health, the application of the simplified or fast I – The consistency and coherence of the ex- control regime shall be immediately suspended. porter country’s agriculture and livestock health Art. 101. In addition to the legal require- and inspection legislation; ments of the importing countries, the require- II – The organization and functioning of the ments of these Regulations and of the current exporter country’s official services, and compe- sanitary and phytosanitary legislation must be tent authorities and their attributions and au- met in connection with the exportation or reex- tonomy; portation of animals, plants, inputs – including III – The personnel’s and team’s qualification animal feed – and animal and plant products. for the performance of the official controls; IV – The infrastructure in place, including evaluation undertaken, including pertinent rec- diagnostic laboratories and facilities; ommendations. V – The existence and functioning of control Art. 106. The Ministry of Agriculture, Live- procedures; stock, and Food Supply as Central and Superior VI – The situation of animal health, zoonoses, Organ may request from exporting countries in- and sanitary and phytosanitary control, and pro- formation on the organization and management cedures for the notification of animal and plant of their agriculture and livestock sanitary control disease outbreaks or events; and systems. VII – The guarantees the exporter countries Paragraph 1. Said information shall be can offer of compliance with the national re- checked against the exporting country’s control quirements, or of sanitary equivalence. results. Paragraph 3. The frequency of evaluation of Paragraph 2. Should the exporting country the agriculture and livestock sanitary conditions fail to provide said information or should the in the countries that export to Brazil shall be de- information provided prove incorrect, Brazil will termined on the basis of the following: unilaterally and immediately demand the full I – Risk analysis of the exported products; application of importation controls, without any II – Brazilian legal dispositions; concessions. III – Volume and nature of imports from the Paragraph 3. The Ministry of Agriculture, country in question; Livestock, and Food Supply as Central and Su- IV – Results of previous evaluations done by perior Organ shall determine the form whereby the Ministry of Agriculture, Livestock, and Food information should be collected, compiled, or- Supply as Central and Superior Organ; ganized, and presented as well as the transition V – Results of importation controls; measures meant to give exporter countries time VI – Information received from other or- to prepare said information. gans; Art. 107. The equivalence agreements rec- VII – Information received from internation- ognize that measures applied in the exporting ally recognized sources, such as the World Health country provide guarantees equivalent to those Organization, the Codex Alimentarius, the Inter- applied in Brazil. national Plant Protection Convention, and the Paragraph 1. For equivalence determination, World Organization for Animal Health; the following items shall be evaluated: 43 VIII – Detection of diseases and pests in the I – Nature and content of the certificates that exporting country; must accompany products; IX – Identification of risks associated with II – Specific requirements applicable to ex- animals, plants, and perishable agricultural and ports to Brazil; and livestock products; and III – Audit results. X – Need to investigate emergency situations Paragraph 2. The Ministry of Agriculture, in the exporter country. Livestock, and Food Supply as Central and Supe- Art. 104. Should risk analysis identify risks rior Organ shall prepare and keep current a list of associated with animals, plants, and perishable regions or establishments whose exports to Brazil agricultural and livestock products, the Ministry will not be permitted, taking into consideration of Agriculture, Livestock, and Food Supply as Cen- the equivalence system. tral and Superior Organ will immediately take the Paragraph 3. The recognition of equivalence emergency measures contemplated hereunder or shall be revoked immediately and unilaterally under the provisions of current legislation on the whenever any of the established conditions is protection of agriculture and livestock health. not met. Art. 105. The Ministry of Agriculture, Live- Art. 108. The Ministry of Agriculture, Live- stock, and Food Supply as Central and Superior stock, and Food Supply as Central and Superior Organ shall issue a report on the results of each Organ is hereby authorized to carry out joint initiatives and support neighbor countries in con- Organ’s noncompliance with obligations under nection with the healthiness of animals, plants, the agriculture and livestock sanitary legislation inputs – including animal feed – and animal and and hereunder, susceptible of compromising plant products so as to develop the requisite in- the objectives of the Agriculture and Livestock stitutional capability to meet the conditions re- Health Care Unified System. ferred to hereunder. Paragraph 1. Should the competent authority of the Ministry of Agriculture, Livestock, and CHAPTER VII Food Supply as Central and Superior Organ identify any noncompliance, it shall adopt measures COOPERATION AND ASSISTANCE to ensure that the Intermediate of Local Organ in question may solve the situation. Art. 109. At the request of the competent au- Paragraph 2. In deciding in favor of assis- thorities of the Local Organs and in collaboration tance in view of the Intermediate Organs’ op- with them, the Intermediate Organs shall extend erating or temporary incapacity to comply with cooperation and assistance to the Local Organs. the provisions of the preceding Paragraph 1, the Art. 110. At the request of the competent competent authority of the Ministry of Agricul- authorities of the Intermediate Organs and in ture, Livestock, and Food Supply as Central and collaboration with them, the Ministry of Agricul- Superior Organ shall take into consideration the ture, Livestock, and Food Supply as Central and noncompliance’s antecedents and nature. Superior Organ shall extend cooperation and as- Paragraph 3. The assistance action referred sistance to Intermediate Organs. to in this article’s heading may include one or Sole Paragraph. Cooperation and assistance more than one of the following measures: extended by the Ministry of Agriculture, Livestock, I – Adoption of sanitary procedures or any and Food Supply as Central and Superior Organ other measures deemed necessary to ensure shall encompass particularly the following: the safety of animals, plants, inputs – including I – Clarifications pertaining to national agri- animal feed – and animal and plant products, as culture and livestock health and inspection; well as of norms pertaining to animal health; II – Information and data available at the II – Restriction or prohibition of placement national level that might be useful for the con- of products on the market; trol of Intermediate and Local Organs in ensur- III – Monitoring of products and, if neces- 44 ing the universality, harmonization, equity, and sary, determination that they be recalled, with- effectiveness of the agriculture and livestock drawn, or sent to destruction; health controls and actions; and IV – Authorization for the use of inputs – III – Operating support required for controls including animal feed – and animal and plant under the responsibility of the Intermediate and products for a purpose different from their origi- Local Organs under the Agriculture and Livestock nal purpose; Health Care Unified System. V – Suspension of operations or outright Art. 111. The Intermediate Organ shall adopt closing of part of production activities or of en- emergency and temporary assistance measures terprises; in case of a Local Organ’s noncompliance with VI – Suspension or cancellation of accredita- obligations under the agriculture and livestock tion; and sanitary legislation and hereunder, susceptible of VII – Any other measures deemed appro- compromising the objectives of the Agriculture priate by the Ministry of Agriculture, Livestock, and Livestock Health Care Unified System. and Food Supply as Central and Superior Organ’s Art. 112. The Ministry of Agriculture, Live- competent authority. stock, and Food Supply as Central and Superior Paragraph 4. The burden of the actions re- Organ shall adopt emergency and temporary as- ferred to under Paragraph 3 above shall be born sistance measures in case of and Intermediate by the producers of animals, plants, inputs – including animal feed – and animal and plant or at their own initiative, assist each other when- products, appeal being possible as prescribed by ever the results of official controls show the need the Ministry of Agriculture, Livestock, and Food for the adoption of emergency measures in more Supply as Central and Superior Organ. than one Intermediate Organ. Art. 113. Penalties for infractions related Sole Paragraph. Mutual assistance among to agriculture and livestock health shall be im- Intermediate Organs may include, as the case posed as prescribed under specific federal, state, may be, participation in local controls under- and municipal legislation. taken by a competent authority from other In- Art. 114. All Agriculture and Livestock termediate Organs. Health Care Unified System procedures must be Art. 119. Should a Three Organs’ competent documented. authority have knowledge of a case of noncom- Art. 115. In case of noncompliance with ag- pliance and such case is likely to have implica- riculture and livestock health norms on the part tions for the Agriculture and Livestock Health of producers of animals, plants, inputs – includ- Care Unified System and for another Intermedi- ing animal feed – and animal and plant prod- ate Organ, it shall promptly convey such informa- ucts, producers at fault shall be formally notified tion to the Ministry of Agriculture, Livestock, and by the competent authority. Food Supply as Central and Superior Organ and to other Intermediate Organs, without any need Section I for a prior request. Crisis Control Paragraph 1. The Organs receiving such in- Art. 116. The Agriculture and Livestock formation shall start investigations and shall in- Health Care Unified System shall have a Crisis form the Organ that provided the information Management Procedures Manual and Special of the investigations’ results and, as the case Groups for Agriculture and Livestock Health Ac- may be, of the measures adopted, particularly tion, which shall abide by specific norms issued the application of the assistance received with- by the Ministry of Agriculture, Livestock, and out prior request. Food Supply. Paragraph 2. Should the competent authori- Art. 117. For the implementation of the ties of the Organs involved have reason to suspect guidelines contained in the Crisis Management that these measures are inadequate, they should Procedures Manual, the Agriculture and Live- seek together ways and means of addressing the 45 stock Health Care Unified System’s Three- Or noncompliance. gans shall proactively prepare contingency and Paragraph 3. The Intermediate Organs emergency plans defining readily applicable shall inform the Ministry of Agriculture, Live- measures whenever there is a risk to agricul- stock, and Food Supply as Central and Superior ture and livestock health, whether directly or Organ if they fail to reach a consensus on ad- through the environment. equate measures or if the noncompliance may Paragraph 1. The contingency and emergen- affect the Agriculture and Livestock Health Care cy plans shall specify the administrative authori- Unified System as a whole. ties that must intervene, their respective powers Paragraph 4. Should it be concluded that and attributions, and the channels and proce- the noncompliance may affect the agriculture dures for the exchange of information among the and livestock health in the region or in the entire different interveners. country, the Ministry of Agriculture, Livestock, Paragraph 2. The Intermediate Organs shall, and Food Supply as Central and Superior Organ within their areas of competence, review and shall provide assistance without prior request to adapt the contingency and emergency plans to the area identified. their specific conditions. Art. 120. The Ministry of Agriculture, Live- Art. 118. The Intermediate Organs shall, stock, and Food Supply as Central and Superior within their areas of competence and by request Organ shall suspend the application of sanitary and phytosanitary measures among Organs of Health Multiyear Plan should contain general in- the Agriculture and Livestock Health Care Uni- formation on the following: fied System, which are unwarranted or contrary I – The plan’s strategic objectives and how to the agriculture and livestock health legislation, they reflect on the setting of priorities and alloca- and shall adopt pertinent measures. tion of resources; II – Category or classification of the risks as- CHAPTER VIII sociated with the activities; III – Designated competent authorities PLANNING and their respective attributions in their different spheres of action, and the resources Art. 121. The Ministry of Agriculture, Live- available to them; stock, and Food Supply as Central and Superior IV – Organization and management of offi- Organ shall establish Agriculture and Livestock cial controls, including official controls at the dif- Health, strategic, and executive multi-year plans, ferent establishments; in coordination with the Agriculture and Live- V – Control systems applied and coordina- stock Health Care Unified System’s Three Organs. tion among competent authorities responsible These plans shall: for official controls; I – Be prepared every five years with the VI – Possible delegation of tasks; participation of the social segments and govern- VII – Methods for ensuring the observance of ments involved, and be subjected to yearly re- operating criteria; view; VIII – Training of the personnel in charge of II – Serve as reference for the preparation of official controls; the Federal Government’s Multi-year Plan, and IX – Documented procedures; similar state , and municipal plans and their re- X – Preparation and implementation of con- spective plans of action; and tingency and emergency plans in case of diseases III – Be organized and executed in function and pests of significant impact, and other risks; of hazards identified and related to animals, XI – Organization of mutual cooperation and plants, inputs – including animal feed – and ani- assistance; mal and plant products. XII – Institutional coordination mecha- Paragraph 1. The Agriculture and Livestock nisms; and 46 Health Multiyear Plans shall establish the goals, XIII – Collegiate bodies and cooperation and objectives, and responsibilities for each Organ, as assistance systems, such as rural extension. well as the requisite resources, including finan- Paragraph 2. The Agriculture and Livestock cial counterparts and financing sources. Health Multi-year Plans may be altered as they Paragraph 2. The Ministry of Agriculture, are being executed. Livestock, and Food Supply shall define how re- Paragraph 3. Alterations shall take the fol- sources are to be applied, all in accordance with lowing into consideration: the pertinent legislation. I – Emergence of new diseases or pests of Paragraph 3. The Three Organs shall assume significant impact or of other risks; responsibility for the application of resources and II – New legislation and adjustments defined for full compliance with the jointly established Ag- by the Central and Superior Organ; riculture and Livestock Health Multi-year Plans. III – Significant adjustments in the structure, Art. 122. The Ministry of Agriculture, Live- management, or functioning of the competent stock, and Food Supply as Central and Superior authorities; Organ shall establish the timetable for the prepa- IV – Results of fiscal controls undertaken ration and updating of the Federal Government’s under the Agriculture and Livestock Health Care Multiyear Plan. Unified System; Paragraph 1. The Agriculture and Livestock V – Scientific discoveries; VI – Suggestions from technical consultant IV – Recommendations for improving the ex- services rendered by the Three Organs or from ecution of the activities called for under the Agri- international technical missions; and culture and Livestock Health Multiyear Plans. VII – Results of audits performed by the Cen- Art. 124. The report shall be submitted to the tral and Superior Organ. National Agricultural Policy Council, which will for- Paragraph 4. The Agriculture and Livestock ward it with its recommendations to the Ministry Health Multi-year Plans shall observe the fol- of Agriculture, Livestock, and Food Supply, which in lowing: turn will publicize it to the general public. I – Consistent, global, and integrated approach to legislation; CHAPTER IX II – Priorities set in view of the risks; III – Criteria for grading and classifying the RESOURCES AND FINANCING risks of activities; IV – Control and correction procedures; Art. 125. It is incumbent upon the Three V – International, multilateral, or bilateral Organs to guarantee the necessary resources for commitments pertaining to agriculture and live- Agriculture and Livestock Health Care Unified Sys- stock health; tem’s activities in their respective jurisdictions, in VI – Indicators in the stages of the produc- accordance with the pertinent legislation. tion chain that will provide information on com- Paragraph 1. The Agriculture and Livestock pliance with the agriculture and livestock sani- Health Care Unified System Organs may levy fees tary legislation; or charges, pursuant to their respective legisla- VII – Good practices systems at all stages of tion, to defray the costs incurred during official the production chains; controls; duplication of charges for services ren- VIII – Traceability control systems; dered is hereby forbidden. IX – Performance evaluation systems and Paragraph 2. Should different official con- results of control actions, including performance trols be undertaken simultaneously at a given indicators; establishment, the competent authority should X – Norms and recommendations of refer- consider them as a single activity and levy only ence international organizations; one charge for them. XI – Auditing criteria; and Paragraph 3. A receipt must be obligatorily 47 XII – Structure of annual reports and infor- issued, pursuant to regulations, each time charges mation they should contain. are collected. Art. 123. A year after the beginning of the Art. 126. Based on their own legislation, implementation of the Agriculture and Livestock the Agriculture and Livestock Health Care Uni- Health Multi-year Plans and every year thereafter, fied System Organs may set differentiated fees progress reports shall be prepared on the work for services rendered or establish exemptions in done by the Ministry of Agriculture, Livestock, specific cases. and Food Supply as Central and Superior Organ, Art. 127. The Agriculture and Livestock indicating the following: Health Care Unified System Organs shall publicize I – Changes proposed or introduced in the their schedule of rates applicable to their services Agriculture and Livestock Health Multiyear Plans; or activities. II – Results of controls and audits performed Art. 128. The Agriculture and Livestock the previous year, as provided under the Agricul- Health Care Unified System Organs may charge ture and Livestock Health Multiyear Plans; for expenses incurred with additional controls, III – Type and number of cases of noncom- should any noncompliance detected entail offi- pliance identified and geographic location of cial controls or corrective measures that exceed major events, preferably with the use of elec- the competent authority’s regular activities, in ac- tronic maps; and cordance with the pertinent legislation. Sole Paragraph. Activities that exceed regu- ricultural and Livestock Products and Inputs are lar activities include corrective measures and oth- hereby established, as follows: er additional controls to determine the problem’s I – Brazilian Plant Products Inspection seriousness and its solution. System; Art. 129. The Ministry of Agriculture, Live- II – Brazilian Animal Products Inspection stock, and Food Supply as Central and Superior System; and Organ may suspend the transfer of resources to III – Brazilian Agricultural and Livestock In- the Intermediate and Local Organs in the follow- puts Inspection System. ing cases: Paragraph 1. The Brazilian Agricultural and I – Noncompliance with these Regulations Livestock Products and Inputs Inspection Sys- and other specific agriculture and livestock health tems shall carry out the following activities: norms; I – Auditing, inspection, control, certifica- II – Failure to carry out the activities and tion, and classification of plant products, their achieve the goals envisaged under the Multi-year byproducts, subproducts, and residues of eco- Agriculture and Livestock Health Plans and in spe- nomic value; cific projects, should justifications alleged by the II - Auditing, inspection, control, certifica- pertinent Intermediate and Local Organs author- tion, and classification of animal products, their ity be deemed unwarranted; byproducts, subproducts, and residues of eco- III – Lack of proof of the corresponding coun- nomic value; terproof; III – Auditing, inspection, control, and cer- IV – Irregular application of financial resourc- tification of inputs and services used in agricul- es transferred; tural and livestock activities. V – Lack of proof of the regular feeding Paragraph 2. The activities of the Brazilian and feedback of epidemiologic information Agricultural and Livestock Products and Inputs systems; and Inspection Systems shall be carried out in ac- VI – Lack of timely compliance with formal cordance with current agriculture and livestock requests for information. health and inspection and with the international Sole Paragraph. After analyzing justifications commitments undertaken by Brazil. alleged by Intermediate and Local Organs that Paragraph 3. Auditing, inspecting, and con- have led to the suspension of resources transfer, trolling shall be done without advance notice, ex- 48 the Ministry of Agriculture, Livestock, and Food cept in specific cases when advance notice must Supply as Central and Superior Organ may, on the be given the person in charge of production. basis of reasoned technical opinion, resume the Paragraph 4. Auditing, inspecting, and con- transfer of financial resources, extend assistance trolling shall be done at any stage of production, without prior request, maintain the suspension of processing, storage, or distribution. resources transfer, or withdraw recognition of the Paragraph 5. Auditing, inspecting, and con- defaulting Organ. trolling as envisaged under the preceding Para- graph 4 shall not be required in connection with CHAPTER X foodstuffs, beverages, and water for human consumption under the responsibility of the sanitary INSPECTION OF AGRICULTURAL surveillance organs that form part of the Unified AND LIVESTOCK PRODUCTS AND INPUTS Health System (SUS). Paragraph 6. For inspections, hazard analy- Art. 130. As part of the Agriculture and Live- sis and critical control points method may be stock Health Care Unified System and for the pur- used, at the competent authority’s discretion. pose of inspecting and controlling animal and Paragraph 7. Audits, inspections, and con- plant products and agricultural and livestock trols shall encompass all animal and plant inputs, the Brazilian Systems of Inspection of Ag- products and agricultural and livestock inputs, imported or domestically produced, whether tems, the Ministry of Agriculture, Livestock, and destined for exportation or not. Food Supply, the States and the Municipalities Paragraph 8. At the competent authorities’ shall ensure the following: discretion, inspections may be done on a continu- I – That inspections and controls will be ef- ous basis at industrial or agro-industrial plants. fective and appropriate at all stages of the pro- Art. 131. The Ministry of Agriculture, Live- duction chains; stock, and Food Supply as Central and Superior II – That the technical and support person- Organ shall coordinate the Brazilian Agricultural nel in charge of inspections and controls will be and Livestock Products and Inputs Inspection hired solely through public competitive exams; Systems. III – That the technical and support person- Paragraph 1. The States may join the Bra- nel in charge of inspections and controls will zilian Agricultural and Livestock Products and have no conflict of interest; Inputs Inspection Systems. IV – That there will be official or accredited Paragraph 2. The Municipalities may also laboratories or access to such laboratories with join the Brazilian Animal Products Inspection adequate capacity to perform tests, and staffed Systems and the Brazilian Plant Products Inspec- with qualified, experienced personnel in suf- tion System. ficient number to perform the official controls Paragraph 3. The Ministry of Agriculture, efficiently and efficaciously; Livestock, and Food Supply shall, within ninety V – That there will be adequate, well-main- days of the publication of these Regulations, tained facilities and equipment to ensure that establish the requirements and procedures for the personnel will be able to do inspections and joining the Brazilian Agricultural and Livestock controls safely and effectively; Products and Inputs Inspection Systems. VI – That there will be assurance of the req- Paragraph 4. To join the Brazilian Agricul- uisite legal powers to undertake inspections and tural and Livestock Products and Inputs Inspec- controls and that the measures contemplated tion Systems, the States must adapt their inspec- hereunder will be adopted; tion and control processes and procedures. VII – That controls and sanitary education Art. 132. The States, the Federal District, activities will be assured; and the Municipalities that have not joined or VIII – That no industrial establishment or that have decided not to join the Brazilian Ag- entrepot will be able to function in the country 49 ricultural and Livestock Products and Inputs In- without prior registration with the competent spection Systems shall have their inspection and organ charged with oversight of its activity; control of animal and plant products and of ag- IX – That clandestine activities will be effec- ricultural and livestock inputs recognized solely tively combated; and within their own jurisdictions. X – That rural and industrial producers and Paragraph. 1. Subject to a formal request, input suppliers, distributors, cooperatives, as- the Federal Government may provide technical sociations, industrialists and agribusiness entre- cooperation to the States, just as the States may preneurs, wholesalers and retailers, importers cooperate with the Municipalities. and exporters, and other entrepreneurs and Paragraph 2. The Ministry of Agriculture, operators along the production chain will be Livestock, and Food Supply shall perform yearly subjected to inspections or controls performed audits in the inspection services of the States, pursuant to the regulations hereunder and will Territories, and Municipalities. support the competent authority in the fulfill- Paragraph 3. The States shall perform ment of its mission. yearly audits in the Municipalities under their Sole Paragraph. By joining the Brazilian jurisdiction. Agricultural and Livestock Products and Inputs Art. 133. By joining the Brazilian Agricultural Inspection Systems, the States and Municipalities and Livestock Products and Inputs Inspection Sys- undertake the commitment to abide by the federal legislation or to have equivalent regulations, Art. 139. The competent authorities of the approved pursuant to the provisions hereunder Brazilian Agricultural and Livestock Products and and to specific norms pertaining to the inspec- Inputs Inspection Systems shall ensure the impar- tion of animal and plant products, as well as of tiality, quality, and consistency of official controls. agricultural and livestock inputs. Art. 140. Whenever official control func- Art. 134. The Brazilian Agricultural and Live- tions are delegated to different public insti- stock Products and Inputs Inspection Systems shall tutions, the delegating competent authority be responsible for ensuring that the procedures shall ensure the coordination and cooperation and organization of the inspection of animal and among said institutions. plant products, as well as of agricultural and live- Art. 141. Mechanisms shall be established stock inputs will use universal methods equitably for the interaction between the Brazilian Ag- applied in all inspected establishments. ricultural and Livestock Products and Inputs Art. 135. Audits and technical evaluations Inspection Systems and teaching and research shall be geared to the organization, structuring, institutions with a view to the ongoing training, and proper systematization of inspections and qualification, and education of the profession- controls in the country and to the improvement of als involved. the Brazilian Agricultural and Livestock Products and Inputs Inspection Systems, and shall be per- Section 1 formed according to the following procedures: Animal Products Inspection and Control I – The States inspection services shall be Art. 142. The hygiene and sanitary, tech- evaluated by the Ministry of Agriculture, Live- nological, and industrial inspection of animal stock, and Food Supply; and products is incumbent upon the Federal Govern- II – The Municipal inspection services shall ment, the States and the Municipalities. be evaluated by the States according to their Paragraph 1. All animal products, whether geographical areas of operation. they are edible or not, with or without the addi- Paragraph 1. The Ministry of Agriculture, tion of plant products, must be inspected from Livestock, and Food Supply shall provide guid- both an industrial and a sanitary standpoint. ance to the State, and Municipal inspection ser- Paragraph 2. Inspection of animals is done vices as regards compliance with the legal provi- both ante- and post-mortem and encompasses sions hereunder. the receiving, handling, processing, preparation, 50 Paragraph 2. Any corrective measures ad- conservation, conditioning, packaging, stor- opted shall be communicated to the organiza- age, labeling, transportation, and consumption tions representative of society, region, or af- of any products, subproducts, and residues of fected sectors. economic value, with or without the addition of Art. 136. Activities under the Brazilian Ag- plant products, whether or not they are destined ricultural and Livestock Products and Inputs for human consumption. Inspection Systems that are incumbent on the Art. 143. No industrial establishment or States , and Municipalities shall be carried out by entrepot dealing with animal products may op- public institutions duly recognized by the Minis- erate in the country without being registered try of Agriculture, Livestock, and Food Supply. with the competent organ to ensure the inspec- Art. 137. The States and Municipalities shall tion of its activity. designate civil servants as members of teams that will act as the authorities responsible for the in- Section II spections and controls contemplated hereunder. Inspection of Plant Products and Control Art. 138. The States and Municipal compe- Art. 144. The hygiene and sanitary, technolog- tent authority may delegate competences per- ical, and industrial inspection of animal products taining to inspection and control to one or more is incumbent upon the Federal Government, the than one public institution. States and the Municipalities. Art. 145. The Brazilian Plant Product In- spections and controls follow the norms and spection System’s purpose is to ensure the iden- criteria preestablished by the Brazilian Agri- tity, quality, conformity, fitness, and hygiene and cultural and Livestock Products and Inputs In- sanitary as well as technological safety of animal spection Systems. products, subproducts, byproducts, and residues Art. 151. The State and Municipal inspection of economic value through the inspection, con- services shall apply to the Ministry of Agriculture, trol, and classification of products, systems, or Livestock, and Food Supply for verification and production chain, as the case may be. recognition of their equivalence for engaging in interstate trade, in conformity with the procedures Section III for joining the Brazilian Agricultural and Livestock Inspection of Agricultural and Livestock Products and Inputs Inspection Systems. Inputs Sole Paragraph. After the requisite docu- Art. 146. The hygiene and sanitary, tech- mentation is reviewed and approved, documen- nological, and industrial inspection of animal tal and operational audits in the State or Munici- products is incumbent upon the Federal Govern- pal inspection services shall be done by the com- ment, the States and the Municipalities. petent authorities of the Ministry of Agriculture, Art. 147. The Brazilian Agricultural Inputs Livestock, and Food Supply for their adherence Inspection and Control System and the Brazil- to the System. ian Livestock Inputs Inspection and Control Art. 152. The State and Municipal services System are hereby established and shall be joining the Brazilian Agricultural and Livestock structured and organized under the coordina- Products and Inputs Inspection Systems shall be tion of the Ministry of Agriculture, Livestock, recognized as equivalent for the carrying out of and Food Supply. The two systems shall be their activities, provided they follow the federal responsible for the activities pertaining to the norms and regulations and meet the require- inspection and control of agricultural and live- ments established by the Agriculture and Livestock stock inputs. Health Care Unified System and by the Ministry of Art. 148. The purpose of the Brazilian Ag- Agriculture, Livestock, and Food Supply, and pre- ricultural Inputs Inspection and Control System serve their original administrative features. and the Brazilian Livestock Inputs Inspection and Paragraph 1. The States and Municipalities Control System is to ensure the identity, quality, shall ensure that all products, whether or not 51 conformity, fitness, and hygiene and sanitary as they are destined for the local, regional, or na- well as technological safety of animal products, tional market, are inspected and controlled with subproducts, byproducts, and residues of eco- the same rigor. nomic value through the inspection, control, and Paragraph 2. The competent authorities at classification of products, systems, or production the destination must check compliance with the chain, as the case may be. legislation on animal and plant products through nondiscriminatory controls. Section IV Paragraph 3. The States and Municipali- Equivalence of Services ties may request specific technical information Art. 149. The Ministry of Agriculture, Livestock, from the official services that have authorized and Food Supply, the States and the Municipalities the delivery of goods from other States or other shall adopt the requisite measures to ensure that Municipalities. the inspection and control of animal and plant Paragraph 4. The States and Municipalities products and inputs are done in a uniform, har- that approve establishments located on their monious, and equivalent manner in all States and territory pursuant to their respective legislation Municipalities. must inform the Ministry of Agriculture, Live- Art. 150. The Ministry of Agriculture, Live- stock, and Food Supply and the other States and stock, and Food Supply shall ensure that in- Municipalities accordingly. Art. 153. The requirements for recognition and the management programs pertaining to of the equivalence and qualification of inspec- programs, actions, audits, and other activities tion services under the Brazilian Agricultural and necessary for the inspection of animals, plants, Livestock Products and Inputs Inspection Systems and inputs. are as follows: I – Formal application, in conformity with the CHAPTER XI requirements and criteria established by the Min- istry of Agriculture, Livestock, and Food Supply; FINAL DISPOSITIONS II – Submission of an inspection and control work plan; and Art. 156. The competent authorities of the III – Proof of the existence of a structure and Agriculture and Livestock Health Care Unified staff consistent with their functions. System’s Three Organs and of public services Sole Paragraph. The application for rec- connected with the Brazilian Agricultural and ognition of the inspection services of States and Livestock Products and Inputs Inspection Sys- Municipalities shall be reviewed by the Minis- tems shall ensure that their activities are car- try of Agriculture, Livestock, and Food Supply, ried out with transparence; to this end, they which will undertake technical and administra- shall grant the public access to relevant infor- tive audits. mation in their possession, particularly as re- Art. 154. Public inspection services under gards control activities. the Brazilian Agricultural and Livestock Products Sole Paragraph. Agriculture and Livestock and Inputs Inspection Systems shall be disquali- Health Care Unified System’s Three Organs fied in the following cases: and the authorities in charge of public ser- I – Noncompliance with the norms or with vices connected with the Brazilian Agricultural the approved activities and goals called for under and Livestock Products and Inputs Inspection the work plan, which might compromise the ob- Systems shall have available mechanisms for jectives of the Agriculture and Livestock Health preventing that confidential information to Care Unified System; which they gain access as they undertake of- II – Failure to feed the information system ficial controls, which, by its nature, is covered and to keep it current; and by professional confidentiality. III – Failure to comply in a timely manner Art. 157. The Ministry of Agriculture, Live- 52 with formal requests of information. stock, and Food Supply is hereby authorized, in Art. 155. To achieve the objectives of the conformity with the legislation and within its Brazilian Agricultural and Livestock Products area of competence, to enter into agreements and Inputs Inspection Systems, the Ministry of with public entities to ensure complementary Agriculture, Livestock, and Food Supply shall support for field actions pertaining to agricul- develop, on an ongoing basis, the planning ture and livestock health and inspection.

DECREE No. 27.932, OF MARCH 28, 1950

Published in the Official Federal Gazette of march, 30, 1950, Section 1, Page 4873

Approves regulations on the implementation of animal health and inspection mesures.

The President, by the powers invested in him 569, of December 21, 1948, hereby declares: on article 87, paragraph I of the Constitution, and Art. 1. The regulation that accompanies this in view of the disposition on article 8 of Law nº is approved and signed by the Secretary of States for Agricultural Matters, in reference to the mea- Art. 2. This Decree shall take effect on the sures for animal health and inspection mesures date of the publication, being revoked any con- referred to Law nº 569, of December 21, 1948. trary dispositions.

Rio de Janeiro, March 28, 1950, 129th of the Independence and the 62nd of the Republic.

EURICO G. DUTRA CARLOS DE SOUSA DUARTE

REGULATION CONCERNING THE APPLICATION OF MEASURES FOR SANITARY ANIMAL HEALTH AND INSPECTION, AS STATED IN LAW No. 569, OF DECEMBER 21, 1948.

Art. 1. The slaughter of animals contaminat- tee as per the art. 5 of Law 569, of December 21, ed with any zoonosis specified in the following 1948, and stating the name of the representa- article and the destruction of objects and rural tive from the Federal Government who will be in constructions, as public health interest or protec- charge of the Committee Presidency. tion and rural constructions, are hereby autho- Paragraph I. If there is a Rural Association in rized by Director of the Animal Health and In- the region, he/she shall be named the president spection Department (D.D.S.A), National Animal who can delegate to another trusted member Production Department (N.P.A.), the Secretary of the right to represent him/her on the Evaluation Agriculture, by proposition of the Regional Chief Committee. of Inspection, in the same Division, and whose Paragraph II. In the event that there is no jurisdiction the application of the referenced Rural Association in the region, a farmer of re- measures applies. nowned ability, chosen by the interested party, Paragraph I. The compliance with the pro- shall be nominated to replace the representative visions in this article shall be carried out in the of that entity. least amount of time possible, after the evalua- Paragraph III. When the measures stated by tions mentioned in articles 5 and 6. art 1 shall be taken in the Capital, the provisions Paragraph 2. If the reason for the slaugh- in this article, in the scope of the Regional Chief ter of animals justifies immediate attention and Inspector, will be taken by the Director of Animal 53 is out of the Federal District, the authorization Health and Inspection Division. might be given by the Regional Chief Inspec- Art. 4. When a ruling is made pursuant to the tor, and later ratified by the Director of Animal previous article, the authority who draws it up will Health and Inspection Division. communicate his/her decision to the state body Art. 2. Animals are subject to slaughter if and to the proper Rural Association, or the latter contaminated by diseases such as glanders, ra- and the interested party, according to what is stat- bies, pseudorabies, tuberculosis, pullorum dis- ed in paragraph II of the previous article, who will ease, classical swine fever and any other infec- be responsible for taking the necessary measures tious diseases not officially recognized as existing to have their representative present at the location in the Country, as well as any others that came in where the animals will be sanitary slaughtered or contact, direct or indirect, with sick animals, be- objects or rural constructions destroyed. ing considered suspected of contamination and Art. 5. The assessment of the animals to be could pose a threat of dissemination of the dis- sanitary slaughtered will be made based on its ease as determined by the health authority. value in face of racial characteristics, age, gender, Art. 3. When the slaughter is authorized, pur- economic purpose and other elements, per the suant to article 1 of this Regulation, the Regional committee’s judgment. Chief Inspector of Animal Health Protection shall Sole paragraph. In the case of things or ru- issue order designating the Evaluation Commit- ral buildings, the assessment will be made based on the estimated expenses that, determined by rabies, pseudorabies or any other considered in- the Committee, will be necessary to rebuild or curable or lethal. acquire the objects. Art. 9. After the arbitration of the indemni- Art. 6. The assessment of the animal must fication, the Evaluation Committee will issue an be done immediately after its slaughter and evaluation report, with three copies, of which necropsy, performed before the Evaluation Com- the first will be given, as notice, to the interested mittee, in order to confirm the diagnoses. party, the second will be sent to the DDSA, to be Paragraph 1. After the necropsy, samples attached to the indemnification process which will be collected for further tests at the DNPA will be initiated by request of the interested par- laboratory, in case there are questions regarding ty, pursuant to article 10, and the third will be the diagnostics. filed with the respective Regional Inspector or the Paragraph 2. As determined by the Evalua- DDSA, in case it occurs in the Capital. tion Committee, in case there is conditional use Paragraph 1. The assessment report men- of the animal, the slaughter shall be done at the tioned in this article, in addition to other details, nearest slaughterhouse, and the Regional In- as determined by the Committee shall contain: spector shall be responsible for taking measures a) declaration of slaughter of the animal or to avoid any possibility of dissemination of the animals and the destruction of objects or rural disease. buildings; Art. 7. The disposal of bodies, objects and b) owner’s name, nationality, residence and buildings shall be made by deep burial or fire, profession; depending on the case. c) species, breed, approximate age, mark Art. 8. The value given by the Evaluation Com- and other characteristics of the animal or ani- mittee to the sanitary slaughtered animals and mals sanitary slaughtered; objects and buildings destroyed, pursuant to art. 5 d) nature of the objects and description of and paragraph shall be the basis to calculate the the buildings destroyed; indemnification referred by article 1 of Law 569, of e) assessed value of the animal or animals December 21, 1948, per the following items: and the objects or buildings, pursuant to art. 5; I – the indemnification amount shall corre- f) necropsy report referred in art. 6; spond to the total assessed value: g) test result referred in paragraphs 1 to 6 if a) when it is not by the necropsy or later tests; it is the case; 54 b) when it is referred to objects or rural h) assessment amount, calculated according buildings, with confirmed diagnoses. to item in art. 8. II – if diagnosed with tuberculosis, the in- Paragraph 2. There can be recourse to the demnification amount shall be a fourth of the Evaluation Proceeding, within thirty days, to the assessed value. Minister of Agriculture, through the Regional III – the indemnification amount shall cor- Chief, and it should be filed: respond to half of the assessed value for all other a) by a representative of the Federal Govern- cases, with exceptions stated in paragraph II of ment, when it is thought that the evaluation is ex- this article. cessive or the indemnification is not applicable; Paragraph 1. When there is conditional use; b) by the owner of the animal, objects or ru- the indemnification amount will be the differ- ral premises, when the indemnification is denied ence between what is determined per this article or the evaluation is considered insufficient. and the amount received from the use, with valid Paragraph 3. The established period in the proof, except in the case of breeders with racial previous paragraph will begin as of the date of characteristics of zootechnical value, in which filing, if the recourse is filed by the Federal Gov- case there will be no discount. ernment representative, or as of the date the Paragraph 2. There will be no indemnifica- notification is received, if the recourse is filed by tion when the zoonosis causing the slaughter are the interested raiser. Art. 10. The interested raiser will have 90 Sole paragraph – The deadline referred by (ninety) days to request the rightful indemnifica- this article will started as of the date that the tion to the Minister of Agriculture, through the animal is slaughtered or object is destroyed; Regional Chief Inspector in the States or the Direc- however, the resolution for the request will de- tor of the D.D.S.A., in the capital, who will forward pend on the previous recourse decision, if it is the request with the process that contains the ele- the case. ments for the indemnification arbitration and in- Art. 11. The indemnification payment pro- dicate the funds to cover the expenses, according cessing will be considered urgent and shall be to art. 6 and its paragraph, of Law nº 569/48. made in the least amount of time possible.

DECREE No. 24.548 OF JULY 3, 1934

Approves the Animal Health and Inspection Service’s Internal Regulations.

Exercising the powers conferred upon him approved and are to be implemented in the by art. 1st of Decree No. 19,398, dated Novem- country by the Service of Animal Health and ber 11, 1930, the Head of the Provisional Gov- Inspection. ernment of the Republic of the United States Art. 2. All provisions to the contrary are of Brazil, decrees: hereby revoked. Art. 1. The regulations herein issued are

Rio de Janeiro, July 3, 1934, 113th Year of Independence and the 46th of the Republic.

GETÚLIO VARGAS Juarez do Nascimento Fernandes Távora

REGULATIONS OF THE SERVICE OF ANIMAL HEALTH AND INSPECTION 55 CHAPTER I ently healthy state, while the same prohibition is applicable to animals bearing external and PRELIMINARY PROVISIONS internal parasites which, if disseminated, could constitute a threat to the national herds. Art. 1. The Service of Animal Health and In- Art. 3. Also prohibited from entering the na- spection shall implement the prophylactic mea- tional territory are animal products or remains, for- sures specified in these regulations, in such a ages or any other material that may be presumed way as to protect the country from the invasion to bear etiological agents of contagious diseases. of exotic zoonoses and to combat the infectious- Art. 4. The following conditions are essential contagious and parasitic diseases extant in the for entry into the country of animals of foreign territory of the nation. origin: Art. 2. As a means of defending the national a) presentation of a health certificate of ori- herds, a definitive prohibition is imposed on the gin, signed by a government veterinarian; entry into the national territory of any animal b) presentation, according to each case, of that has been attacked or which is under sus- an official certificate of the intradermal tubercu- picion of having been attacked by any diseases, lin test, mallein test, serum agglutination test for that may be either directly or indirectly transmis- diagnostic of brucellosis and pullorum disease. sible, even when such animals are in an appar- Sole Paragraph. The health certificates of origin shall only be valid: Inspection shall demand a serum agglutination a) when they are duly recognized by Brazil- test for S. pullorum and vaccination against ra- ian consular authority of the country of origin of bies of the dogs. the animals; Art. 10. The Ministry of Agriculture shall b) when they attest to the good health of the take those measures deemed necessary to en- animals on the day of shipment; sure that the proper federal, state and munici- c) when they declare that no infectious-con- pal authorities obey and ensure obedience of tagious diseases were epidemic in the place of ori- the present regulations. gin, in the forty day period prior to shipment; Art. 5. Animals originating from countries CHAPTER II where trypanosomosis, rinderpest, contagious bovine pleuropneumonia and other exotic con- PORT AND BORDER INSPECTION tagious diseases exist in epidemic proportions, in and enzootic state will only be permitted to enter Art. 11. The import and export of animals the country with the prior authorization of the Di- will only be permitted through the ports and bor- rector of the Service of Animal Health and Inspec- ders that have been duly equipped by the service tion, who shall determine the conditions under of Animal Health and Inspection. which this import operation will be permitted. Art. 12. Based on the recommendations of Art. 6. The importers should notify the port the board of the Service of Animal Health and and border inspection officials of the time of ar- Inspection, the Minister of Agriculture will des- rival of the animals, at least 24 hours before such ignate the border posts through which animals time. In cases involving exports, the notification may be imported and exported. should be given at least 10 days before the depar- Art. 13. In order to fulfill the terms of article ture of the animals, so that they can be submitted 11, Veterinarian Quarantine Centers will be created to the biological tests referred to in article 4th. at the ports of São Salvador, Santos, Rio Grande, Art. 7. The health certificate of origin shall while that of Rio de Janeiro will be maintained, and remain in the possession of the employee respon- the border posts designated according to the terms sible for the inspection of the animals, who shall of the previous article will be duly equipped. grant a animal movement permit, if the animals Sole Paragraph. The Quarantine Centers re- be found to possess good health conditions. ferred to in this article will be installed as soon as 56 Art. 8. In order to avoid the propagation of budgetary resources so permit. diseases within the national territory, a health Art. 14. Imports and exports of animals are certificate must be supplied for the interstate also subject to the following conditions: transit of animals, by sea, river or land trans- I - that the animals involved be recognized portation, while such a certificate must also be as clinically healthy; provided for animals to be slaughtered for the II - that such animals register no positive supply of the international market. reactions to the government biological tests, no Sole Paragraph. Infractors of this article symptoms of any disease, during the observation shall be subject to a fine of Cr$ 50.00 per animal, period to which they shall be subjected. and double this amount in cases of repetition. Art. 15. Aside from the documents demand- Art. 9. In the case of interstate transport of ed in article 4th, chapter I and its subdivisions, at breeder animals, by sea, aside from the health the moment of the health inspection of imported certificate of origin, the certificate of the intrader- animals, the respective owner or his representa- mal tuberculin test, mallein test and serum agglu- tive should present the following information to tination test for diagnostic of brucellosis should the proper authority: also be presented, depending on the case. a) residence of the owner; Sole Paragraph. Whenever it is deemed b) destination and objective of the import convenient, the Service of Animal Health and operation; c) the number of days spent in travel; bility of the owners of the animals. d) if any death occurred among the animals Art. 20. The sanitary slaughter of the ani- during travel. mals as determined in articles 18 and 19 will take Sole Paragraph. The inspection referred to place in the presence of the responsible employ- in this article should be carried out in full daylight ees of the Service of Animal Health and Inspec- and requested at least 24 hours beforehand. tion and a descriptive statement of this act will be Art. 16. Without the health certificate or license elaborated and signed by the two highest ranking issued by the veterinary authority responsible for employees present, by the owner or consignee of the inspection, the imported animals, together with the animals and by two witnesses. forages, boxes and any utensiles that may accom- Sole Paragraph. At the time of sanitary slaugh- pany the animals, will not be permitted to leave the ter, the owner or his representative shall have the means of transportation utilized in shipment. right to request an autopsy of the animals. Sole Paragraph. The Ministry of Agriculture Art. 21. When the autopsy and other exami- shall take those measures deemed necessary to nations of the sanitary slaughtered animal do not ensure that the port authorities obey and see to show the lesions or pathognomonic characteristics the obedience of this article. of the diseases cited in articles 18 and 19, the own- Art. 17. In exceptional cases, at the discretion er shall have the right to payment of indemnity in of the general director of the DNPA, an animal cash at a value corresponding to the full value of may be permitted to enter the country without the animal and of the objects that accompanied the health certificate of origin, with the condition the animal and which were destroyed. that such an animal be apparently healthy at the Art. 22. In the case of imports through the time of unloading, and that it be considered free port of Rio de Janeiro, the request for autopsy, of disease, after being submitted to observation as referred to in article 21, should be presented quarantine and those tests and biological exami- to the director of the Service of Animal Health nations considered necessary. and Inspection, while in the case of the other Art. 18. Should the presence of rinderpest be ports and border posts cited in article 13, chap- found, all of the ruminants included in the ship- ter II, such a request should be presented to the ment will be immediately sanitary slaughtered and head inspectors or inspectors. all prophylactic measures considered necessary will Art. 23. When, due to the negligence of the be taken, and the owner of such animals shall have responsible, employee, the requested autopsy is 57 no right to indemnity of any kind whatsoever. not carried out within 24 hours of the moment Art. 19. Should the diagnosis show the pres- in which the animal was sanitary slaughtered, ence of tuberculosis, paratuberculosis, conta- the right of the petitioner to the indemnity cited gious bovine pleuropneumonia, trypanosomosis, in article 21 shall be recognized, and the afore- anthrax, blackleg, rabies, pseudorabies, perni- mentioned employee shall be responsible for cious anemia, brucellosis, glanders, sheep, goat the payment of such indemnity. and pig pox, typhus, classical swine fever, conta- Art. 24. Should the diagnosis be confirmed gious caprine pleuropneumonia, malignant ca- by the necropsy, the consequent expenses shall tarrhal fever, avian influenza, fowl typhoid and be the responsibility of the interested party that pullorum disease, only those animals that have requested the necropsy. been attacked will be sanitary slaughtered and Art. 25. The expenses cited in the previous the prophylactic measures deemed necessary in article shall be paid according to the rates deter- each case will be taken, and the owner of such mined by the Ministry of Agriculture, in the form animals shall have no right to indemnity of any of federal revenue stamps, which shall be ren- kind whatsoever. dered useless on the necropsy reports. Sole Paragraph. The expenses consequent Art. 26. In the case specified in article 21, the upon the prophylactic measures taken, according federal government shall be responsible for the to the terms of this article, shall be the responsi- consequent expenses. Art. 27. When the interested party does borders of the states should construct a trough for not agree with the result of the necropsy, he may the control of ticks, as well as corrals for the resting request the immediate carrying out of a new ex- of the animals, with resistant flooring to avoid the amination and, in this case, he may designate a possibility of the animals becoming mired in mud. professional of his confidence to verify the re- Paragraph 1. The animals transported by sults. If the two professionals do not arrive at an river in the barges that are specifically used for agreement, they shall gather authenticated mat- this purpose, shall be subject to obligatory health ter for examination at a DNPA laboratory, which inspection by the Service of Animal Health and shall then resolve the doubt. Inspection. Sole Paragraph. In no case shall the re- Paragraph 2. As soon as the animals have mains of the necropsied cadaver fail to be cre- been unloaded, the barges shall be washed and mated on the same day in which the autopsy disinfected with products approved by the Board was carried out. of the Service of Animal Health and Inspection, Art. 28. In the case specified in article 26, the and the expenses shall be the responsibility of general director of the National Department of the respective owners. Animal Production shall designate a three mem- Art. 32. When transported by railroad, field ber commission, in which the owner or his repre- animals that are destined for slaughter may not be sentative shall participate, to arbitrate the value kept on board for periods of more than 72 hours. of the indemnity, while voluntary appeal to the Sole Paragraph. The railroad companies Minister shall be permitted. should install rest fields for the animals, which Art. 29. The import and export of animals should remain in these fields for at least 24 hours through border posts for purposes of slaughter when travel time exceeds the period specified in shall be permitted, independently of the biologi- this article. cal tests referred to in line II of article 14, chapter Art. 33. In the case of breeding animals that II, with the condition that the animals be in an can be fed during the trips, there is no necessity apparently good state of health, free of ectopara- of observing the period specified in article 32. sites and originate from areas in which infectious- Art. 34. The interstate transit of animals contagious diseases are not epidemic. shipped in a standing position may only be done Sole Paragraph. In this case, notification of through the points previously determined by the the arrival or departure of such animals should be Service of Animal Health and Inspection, on the 58 presented at least 24 hours beforehand, so that the basis of an agreement with the state authorities. respective inspection may be carried out and the Paragraph 1. At the points determined by respective health certificate issued or received. the Service of Animal Health and Inspection, all Art. 30. The signatures of the director of the cattle must be examined on the normal transit Service of Animal Health and Inspection and of the roads and a animal movement permit should be employees authorized to sign certificates for the in- issued when they are found to be free of infec- ternational export of animals shall be sent, in the tious-contagious diseases. quantities demanded by the respective consulates, Paragraph 2. Infractors shall be subject to to the representatives of the governments of those a fine of from Cr$ 50.00 to Cr$ 100.00 per ani- countries that import animals from Brazil. mal, and this amount shall be doubled in the case of repetition. CHAPTER III Art. 35. Animals transported by railroad and destined to the cold storage facilities of slaughter MOVEMENT OF ANIMALS WITHIN houses involved in international exports shall be THE COUNTRY inspected in the corrals and loading chutes or on the farms themselves, by employees of the Service Art. 31. Those companies licensed to oper- of Animal Health and Inspection or by employees ate in the river transportation of cattle along the of the states, when this task has been entrusted to them by the Ministry of Agriculture. exist, the cars or any other vehicles that have Art. 36. Animals destined to other states transported animals to cold storage plants and for slaughter, breeding or fattening shall be ex- slaughter facilities should be cleaned and disin- amined in the corrals or loading chutes by an fected immediately after unloading. employee of the Service of Animal Health and Paragraph 3. Infractors shall be subject to Inspection who shall issue the respective health a fine of from Cr$ 500.000 to Cr$ 1,000.00, such certificate or by employees of the states, accord- amount being doubled in the case of repetition. ing to the terms of the previous article. Art. 40. The methods of cleaning and dis- Paragraph 1. At loading points that do not infecting to be utilized and the disinfecting sub- have a specifically designated employee, the Ser- stances to be adopted shall be determined in in- vice of Animal Health and Inspection shall see to structions to be approved by the Minister. it that the inspection takes place at another local- Art. 41. In cases of epizootic outbreaks, the ity indicated beforehand in special instructions, Service of Animal Health and Inspection may, on before the trains transporting the animals cross the basis of instructions approved by the Minis- the border of the neighboring state. ter, take measures aimed at making those specific Paragraph 2. Trains transporting animals in- in these regulations more severe. fected by foot-and-mouth disease or other diseases, Art. 42. The facilities for disinfecting the when the dissemination of such diseases could con- railroad cattle cars shall be constructed at the ex- stitute a threat to the herds of the region, shall be pense of the companies themselves, which shall impeded from continuing and shall be reconducted also be responsible for the costs of the cleaning to their points of departure, while all expenses shall and disinfecting material and for the payment of be the responsibility of the owners. the personnel demanded for this Service. Paragraph 3. With the exception of special Sole Paragraph.To cover these expenses, the cases, determined at the discretion of the direc- companies shall charge the rates specified in law. tor of the Service of Animal Health and Inspec- Art. 43. The construction projects and bud- tion, the complaints presented by the owners gets of the disinfection facilities shall be orga- of animals that have been impeded from being nized by the transportation companies, on the shipped shall only be considered when the ani- basis of plans supplied by the Board of the Ser- mals are once more at their point of departure or vice of Animal Health and Inspection, and should when they have been reconducted to the same. include specifications as to the channelling of 59 Art. 37. The railroad companies that trans- water, energy, light, drainage of residues and de- port animals are obligated to construct freight tails of the construction. cars considered suitable to the different species. Art. 44. The disinfection facilities will be in- Art. 38. The railroad companies, navigation stalled at the posts indicated by the Board of the companies or any other companies involved in Service of Animal Health and Inspection, while the transportation of animals are obligated to the choice of the localities should be based on clean and disinfect their livestock cars, vehicles, the points that are indicated naturally by the vessels and boxes, as well as the sites of load- traffic, the sidings of slaughter facilities, cattle ing or unloading, corrals, loading chutes and all fairs and expositions. other facilities and localities that have been oc- Art. 45. After being cleaned and disinfect- cupied by the animals. ed, the vehicles, livestock cars or other facilities Art. 39. The demands determined in article may only be withdrawn from the disinfection 38 are subject to the direct inspection of the Ser- centers and utilized, after inspection on the vice of Animal Health and Inspection. part of an employee of the Service of Animal Paragraph 1. The vehicles should be washed Health and Inspection, who shall place a tag on and disinfected within a maximum period of 24 the unit containing the word “disinfected”, to- hours after unloading. gether with the date and his signature. Paragraph 2. When suitable installations Art. 46. In the case of death during transportation, the cadaver should be immediately and transmitted to the health authorities of the necropsied at the site of unloading, in order to es- DNSP, which shall be responsible for inspecting tablish the cause of death and the recommended such products at the consumer centers. health measures that should be applied. Art. 53. In cases involving hides, furs, wool, Art. 47. Infractorts of the health measures horns, hair, etc. for industrial purposes, such determined in the previous article will be subject products shall only be unloaded when the re- to a fine of from Cr$ 300.00 to Cr$ 1,000.00, such spective certificates contain a declaration that amount being doubled in the case of repetition. they originate in areas free of outbreaks of an- Art. 48. The interested parties may take advan- thrax, foot-and-mouth disease and rinderpest. tage of the residual product of the cleaning of the Art. 54. Edible products of animal origin livestock cars for purposes of fertilization, with the elaborated within the country shall only have condition that measures be taken on the basis of a free transit through the ports and border posts process approved by the Service of Animal Health when they originate in inspected establishments and Inspection to make this product harmless. and are accompanied by certificates of hygiene, Art. 49. For the purposes of the provisions supplied by the Inspection Service of Products of of article 42 and in relation to the railroads per- Animal Origin. taining to the federal government, the Ministry Pararaph 1. The certificates referred to in of Agriculture shall come to an agreement with this article shall be valid for a maximum period the Ministry of Transportation in order to trans- of one month and shall be controlled by the com- fer to the latter, on the basis of an assessment, petent employees of the Service of Animal Health the present disinfection centers located in Santa and Inspection. Cruz, Barrra do Piraí and Carlos de Campos, on Pararaph 2. Infractors shall be subject to a fine the “Estrada de Ferro Central do Brasil”. of from Cr$ 500.00 to Cr$ 1,000.00, such amount being doubled in the case of repetition, while clearance CHAPER IV of the products shall be denied to them. Art. 55. Once it has been verified during un- IMPORTS AND EXPORTS OF PRODUCTS loading that the products originated in establish- OF ANIMAL ORIGIN ments registered and inspected by the SIPOA, the certificates accompanying such products will be Art. 50. The import of products of animal recognized and transmitted to the health author- 60 origin is prohibited, when such products are not ities of the DNSP or of the states, for the purposes accompanied by a health certificate supplied by of the provisions of article 52. the proper authority of the country of origin. Art. 56. When products originating in facto- Art. 51. Such certificates will only be valid: ries in the interior of the country are not loaded a) when the models and forms are approved in a single shipment or are destined to diverse by the Ministry Of Agriculture; ports, the employees of the Service of Animal b) when they are recognized by Brazilian Health and Inspection may make multiple use of consular authorities; the certificates accompanying such products, uti- c) when the inspection regulations of the prod- lizing the same models of the SIPOA, indicating ucts of animal origin of the countries of origin are the name and headquarters of the factory and approved by the Brazilian health authorities; the name of the employees who signed the cer- d) when the products originate in inspected tificate of origin. establishments. Sole Paragraph. The certificates of origin Art. 52. The certificates that accompany the should be filed for purposes of control. imported products destined for human consump- Art. 57. Products of animal origin for indus- tion shall be recognized by the employees of the trial purposes that originate in establishments Service of Animal Health and Inspection for the that are not registered in the SIPOA, such as purposes of the provisions of the previous article leathers, wools and hides of wild animals, shall only have free transit when they originate in Sole Paragraph. When the animals origi- areas where there are no current outbreaks of nate in the same state or in areas where there foot-and-mouth disease, in the case of untreated are no outbreaks of infectious-contagious dis- leathers, or anthrax, in any case whatsoever, is ease, the animals will be examined in a locality they are accompanied by the certificate issued by near the fairs before entry into the respective the Service of Animal Health and Inspection. areas of the fairs will be permitted. Pararaph 1. When such products are destined to international commerce, the certificate CHAPTER VI that will permit the shipment of the same will only be provided after disinfection through the INFECTIOUS DISEASES PROPHYLAXIS use of a process approved by the SDSA. Pararaph 2 - Such certificates will be provid- Art. 61. The diseases specified below are ed in the same model used by the SIPOA. subject to the application of the measures of animal health and Inspection determined in CHAPTER V these regulations: Rinderpest - in ruminants; INSPECTION OF MARKETS AND FAIRS Foot-and-mouth disease - in ruminants and OF LIVE CATTLE pigs; Rabies and pseudorabies - in mammals; Art. 58. Live cattle fairs and markets may Tuberculosis - in cattle, pigs and fowl; only operate when they are inspected by the Anthrax - in ruminants, pigs and equines; SDSA and are duly equipped, making it possible Blackleg and Contagious bovine pleuropneu- for the Service to carry out its responsibilities of monia - in cattle; health control. Brucellosis - in ruminants, pigs and equines; Sole Paragraph. The facilities that obey the Salmonellosis - in cattle, pigs and fowls; model approved by the Board of the SDSA shall Pasteurellosis - and mammals and fowl; include a sufficient number of corrals, with resis- Trypanosomosis - in mammals; tant flooring to avoid the possibility of the cattle Piroplasmosis - in ruminants, equines and becoming mired, administrative installations, canines; with an office for the employee responsible for Anaplasmosis - in cattle; 61 the health inspection of the animals, a corral for Glanders - in equines, asses and mules; the isolation of diseased animals, a trough for Enzootic Encephalitis - in equines; the control of ticks and facilities equipped with Classical swine fever - in pigs; an necropsy room and crematorium. Granular vaginitis and malignant catarrhal Art. 59. When cases of infectious-contagious fever - in bovine; disease are found in the animal on exposition, the Coccidiosis - in mammals and fowl; fair will be closed and, in the case of anthrax or Psittacosis, avian spirochaetosis, diphtheria blackleg, all of the animals pertaining to the group and avian influenza - in fowl; in which the disease was found will be vaccinated Scabies - in ruminants, equines, pigs, fowl free of charge, while the interested parties shall be and small domestic animals; responsible only for the cost of the vaccine. Sole Paragraph. At the proposal of the di- Art. 60. The animals form other states that rector of the SDSA based on the results of scien- participate in the cattle fairs should be accompa- tific studies and investigations of any origin, this nied by health certificates supplied by employees list of diseases may be altered by the Minister or of the SDSA, a technical employee of another ser- Agriculture. vice subordinated to the DNPA and duly authorized Art. 62. Measures equivalent to those men- for this purpose, or state employees, in keeping tioned above shall be taken respect to any ani- with the terms of the provisions of article 35. mals of any species that may be bearers of the virus of the diseases cited in the previous article, the paraghaph of article 20. even though such animals may be not suscep- Sole Paragraph. While the clarifying test are tible to those diseases. being carried out, the animal shall be maintained Art. 63. In the interests of animal health in rigorous quarantine and the property or local- and Inspection or public health, the sanitary ity shall be interdicted, without prejudice to the slaughter of all animals infected by the follow- other prophylactic measures that may be recom- ing zoonoses is obligatory: glanders, rabies and mended in each case, while the owner shall be pseudorabies, tuberculosis, pullorum disease, responsible for all expenses involved. classical swine fever. Art. 67. The competent municipal, state and Sole Paragraph. In the case of rinderpest, federal authorities and the veterinary doctors contagious bovine pleuropneumonia, paratu- shall indicate to the employees of the SDSA those berculosis or any other infectious-contagious establishments where an animal has been infect- disease that is not officially recognized as exis- ed or is suspected of bearing one of the diseases tent in the country, it will be obligatory to sani- specified in article 61 or whether there have been tary slaughter both the animals that have been violations of the measures of quarantine isolation infected and those others that may be neces- or interdiction, as defined in these regulations, or sary to defend the nation’s herds. violations of any orders issued for the purpose of Art. 64. The animals that have been infect- avoiding the contagion of such diseases. ed by or are suspected of bearing the diseases Art. 68. Should a transmissible diseases listed in the paraghaph of the previous article occur in one of the normally utilized means of shall, when the sanitary slaughter of the same transportation, at the first point of health inspec- has been requested, will be sanitary slaughtered tion, the vehicle shall be submitted to the most before two witnesses of good repute within a efficient possible disinfection, after the animals maximum period of 24 hours after the owner have been unloaded. or the one responsible for such animals has re- Art. 69. At the discretion of the respon- ceived the order of sanitary slaughter, issued by sible veterinary authority or his representative, the director of the SDSA or by one the head in- all animals that are to take part in expositions spectors of the Regional Inspection offices of the or fairs may be detained for observation, iso- same Service. lation or disinfecting at ports, borders, loading Pararaph 1. When the employee of the Service facilities, roads, etc. 62 of Animal Health and Inspection finds difficulty in Art. 70. In order to avoid the propagation carrying out the measures described in this article, of piroplasmosis and anaplasmosis, the federal he shall request the material support needed to government shall, on the basis of agreements to fulfill his duties from the federal authorities. be made with the local government and when Pararaph 2. Those owners who hinder the financial conditions so permit, set off the areas carrying out of the terms of the present article infested with tics and those free of tics and shall shall be subject to fines of from Cr$ 200.00 to construct troughs for the control of tick infection Cr$ 1,000.00, such amounts being doubled in the in the most suitable points. case of repetition. Art. 71. Measures of a special character in- Art. 65. Animals that have been infected or volving the prophylaxis of each contagious dis- are suspected of bearing contagious diseases and ease will be determined in instructions approved which, in the interests of science, are maintained by the Minister of Agriculture. in quarantine centers and teaching establish- Art. 72. Notification shall be presented by ments or scientific institutions are not subject to the employees of the Service of Animal Health the measures specified in articles 2nd and 3rd. and Inspection to the proper authorities with re- Art. 66. If the owner of an animal scheduled spect to the diseases of fish, feather fowl of hunt for sanitary slaughter contests the diagnosis, it is and furred animals of hunt, as determined in the permitted to proceed according to the terms of regulations of the Service of Hunting and Fishing. CHAPTER VII the Ministry of Agriculture and has the following objectives: VETERINARY ASSISTANCE a) to study and propose to the Minister both complementary measures of animal health and Art. 73. In order to make the efforts against inspection and those specified in these regula- infectious-contagious diseases more efficient, a tions, as well as others which may be deemed service of health advertising, dissemination and necessary; education will be organized and will involve b) to express its opinion on cases that have the free distribution of pamphlets, leaflets, bro- been omitted and on interpretations regarding chures, posters or monographs, as well as con- the carrying out of these regulations; ferences to be proffered by its technical staff. c) to judge, at the level of appeal, the penal- Art. 74. Acting through its technical staff, ties that are applied for infractions against these the Service of Animal Health and Inspection will regulations. provide free cooperation to breeders in the ren- Art. 77. The National Council of Animal dering of veterinary assistance to their herds. Health and Inspection shall be composed of Pararaph 1. The veterinary assistance re- both permanent and consulting members. ferred to in this article will consist of the vacci- Pararaph 1. The following shall be perma- nation and revaccination of the herds, identifica- nent members: tion, prophylaxis and treatment of contagious, The Minister of Agriculture; infectious-contagious, and internal and external The General Director of the National De- parasitic diseases. partment of Animal Production; Pararaph 2. the vaccines and other biological The Director of the Service of Animal Health products utilized in the vaccination and treatment of and Inspection; the herds shall be acquired by the livestock farmers, The Director of the Service of Inspection of while application on the part of the employees of Products of Animal Origin; the SDSA will be entirely free of charge. The Director of the Institute of Animal Bi- Pararaph 3. The transportation of the em- ology. ployees by railroad to the point nearest the farms Pararaph 2. the consulting members shall of the interested party will also be free of charge, be the other directors, the presidents of the na- while transportation will be provided by the inter- tion’s rural associations, assistant heads and the 63 ested parties to such employees from the afore- employees of the technical divisions of the Min- mentioned points to their respective farms. istry of Agriculture, who shall take part in the Art. 75. Requests presented by farmers for meetings when they are called upon by the Min- verification of diseases in animals must be attended ister or by the acting president. following the order in which such requests enter the Pararaph 3. An employee designated by Service of Animal Health and Inspection. the Minister will act as secretary of the National Sole Paragraph. At the discretion of the di- Council of Animal Health and Inspection. rector and the head inspectors, preference will Art. 78. The National Council of Animal be given to those cases which, by their nature, Health and Inspection shall meet at a previous- demand immediate measures. ly determined time, day and locality, under the presidency of the Minister or, in his absence, of CHAPTER VIII the general director of the DNPA who, when un- able to attend, shall be substituted by the Director THE NATIONAL COUNCIL OF ANIMAL of the Service of Animal Health and Inspection. HEALTH AND INSPECTION Art. 79. All of the decisions of the National Council of Animal Health and Inspection shall be Art. 76. The National Council of Animal taken by majority vote of the members present. Health and Inspection is hereby instituted within Art. 80. The Council shall meet and delib- erate with a majority of its members. However, tions will have free access to rural properties, offi- when the subject at hand is not considered ur- cial breeding establishments, storage areas, ware- gent, a copy of the minutes may be sent to those houses, railroad stations, airports, ships whether absent, so that they too can express an opinion they are docked or not, customs facilities or any on the matters discussed. other place where there may exist animals or ani- Sole Paragraph. The decisions of the Na- mal remains to be inspected. tional Council of Animal Health and Inspection Sole Paragraph. The employees cited herein will be published in the Federal Official Gazette. may request the assistance of the public power Art. 81. whether the decisions are taken ac- for those measures which may become necessary cording to the terms of articles 79 or 80, the em- in the implementation of these regulations. ployees responsible for their execution shall be Art. 84. Should it become necessary to notified by the director member of the Council carry out a task of an experimental nature or to whom they are hierarchically subordinate. to acquire knowledge with respect to the work being performed at other establishments, the CHAPTER IX director of the SDSA is hereby authorized to request the collaboration of the heads of these GENERAL PROVISIONS establishments. Art. 85. In the case of tasks performed out- Art. 82. the technical functions involved in side the normal working schedule, at the express animal health and inspection and included in request of private parties the employees involved these regulations shall be exercised by the Ser- shall receive bonuses previously defined in direc- vice of Animal Health and Inspection, in all parts tives issued by the Minister of Agriculture. of the territory of the Republic. Art. 86. The cases omitted from these regu- Paragraph 1. In the carrying out of these lations or which demand posterior instructions regulations, the Service of Animal Health and In- shall be settled by means of directives issued by spection shall further strict collaboration with the the Minister of Agriculture, after the opinion of other services of the DNPA. the National Council of Animal Health and In- Art. 83. By means of the presentation of spection has been duly heard. their professional identity cards, the employees Art. 87. The present regulations shall go into responsible for the carrying out of these regula- effect on the date of their publication. 64 Juarez do Nascimento Fernandes Távora Rio de Janeiro, July 3, 1934 (Published in the Federal Official Gazette, 07.14.34)

COMPLEMENTARY LEGISLATION

DECREE-LAW No. 818 OF SEPTEMBER 5, 1969

Published in the Federal Official Gazette of September 8, 1969, Section I, Page 7569

Provides on the acceptance, by the Ministry of Agriculture, for purposes related to Animal Health and Inspection, of certificates issued by veterinary doctors not connected with Civil Service, and makes other provisions. DECREE-LAW No. 8911 OF JANUARY 24, 1946

Published in the Federal Official Gazette of January 30, 1946, Section I, Page 1511

Provides for the execution of cleaning and disinfection services in means of transportation used in the movement of live animals, and makes other provisions.

ADMINISTRATIVE RULING No. 24 OF NOVEMBER 28, 1977

Published in the Federal Official Gazette of December 16, 1977, Section I, Page 17314

Regulates the accreditation of veterinary doctors not connected with Civil Service.

ADMINISTRATIVE RULING No. 9 OF JANUARY 8, 1970

Published in the Federal Official Gazette of January 13, 1970, Section I, Page 250

Approves the norms pertaining to the acceptance, by the Ministry of Agriculture, of zoosanitary certificates issued by veterinary doctors not connected with Civil Service.

ANIMAL AND PLANT HEALTH AND INSPECTION SECRETARIAT

ADMINISTRATIVE RULING No. 45 OF MARCH 22, 2007 65 Published in the Federal Official Gazette of March 23, 2007, Section I, Page 6

Approves the Animal and Plant Health and Inspection Secretariat’s Internal Regulations, as hereto annexed.

THE MINISTER OF AGRICULTURE, LIVESTOCK, Health and Inspection Secretariat’s Internal Reg- AND FOOD SUPPLY, by virtue of the powers vest- ulations, in the form of the Annex hereto. ed in him by Art. 4 of Decree No. 5351 of Janu- Art. 2. This ADMINISTRATIVE RULING shall ary 21, 2005 and having in view Procedure No. enter into force on the date of its publication. 21000.008272/2005-41, decides as follows: Art. 3. ADMINISTRATIVE RULING no. 574 of Art. 1. To approve the Animal and Plant December 8, 1998 is hereby revoked.

LUÍS CARLOS GUEDES PINTO part II Animal Health and Inspection Programs

NATIONAL PROGRAM FOR THE ERADICATION AND PREVENTION OF FOOT-AND-MOUTH DISEASE

LAW No. 11515 OF AUGUST 28, 2007

Published in the Official Gazette of August 28, 2007, Section 1, Page 1

Modifies provisions of Law No. 569 of December 21, 1948, which establishes animal health and Inspection measures

THE PRESIDENT OF THE REPUBLIC. Know all tered on properties situated on a 150-km wide strip men that the National Congress has decreed and along borders, known as a border strip, and if said I have sanctioned the following Law: animals are sanitary slaughtered owing to the ap- Art. 1. Arts. 6 and 7 of Law 569 of Decem- plication of sanitary measures for combating or ber 21, 1948 shall now enter into force with the eradicating foot-and-mouth disease, full indemnity following modifications, while Art. 6’s Sole Para- shall be paid by the Federal Government. graph shall now become Paragraph 1 of Art. 6: Art. 7. The right to claim the indemnity ex- 66 “Art. 6 …………………………………… pires 180 days as of the date of an animal’s sani- Paragraph 1. …………………………….. tary slaughter or of an item’s destruction.” Paragraph 2. If, under the provisions of the Art. 2. This Law shall enter into force on the preceding Paragraph 1, animals are sanitary slaugh- date of its publication.

Brasília, August 28, 2007, the 186th year of Independence and the 199th of the Republic.

LUIS INÁCIO LULA DA SILVA Reinhold Stephanes Paulo Bernardo Silva

ADMINISTRATIVE RULING No. 4 OF JANUARY 21, 2000

Published in the Official Gazette of February 25, 2000, Section 1, Page 12 Modifies Annex I of Administrative Ruling No. 50 of May 19, 1997 THE MINISTRY OF AGRICULTURE, LIVESTOCK, Ministerial Administrative Ruling No. 574 of De- AND FOOD SUPPLY’S SECRETARY FOR AGRICULTURE cember 8, 1998, hereby resolves as follows: AND LIVESTOCK HEALTH AND INSPECTION, by vir- Art. 1. To modify Annex I to Art. 5 of Admin- tue of the powers vested in him under Art. 83, IV of istrative Ruling No. 50 of May 19, 1996, which this Office’s Internal Regulations approved under shall enter into force as follows:

ANNEX I

FOOT-AND-MOUTH DISEASE RISK LEVEL CLASSIFICATION

BR-D BR-1 BR-3 BR-N BR-2 BR-4 RISK LEVEL NEGLIGIBLE MINIMAL MEDIUM UNKNOWN LOW RISK HIGH RISK RISK RISK RISK RISK Prevention / Prevention Eradication / Limited Prevention / Eradica- Eradication Eradication None Control Pro- Control tion gram Program Total or Coverage Total Total Total Total None partial

Neighboring BR-D or BR-2 or BR-3 or BR-1, BR-2 NR-N - areas’ status BR-1 BR-3* BR-4

Veterinary Fair or None or Good Good Good Good Care System deficient deficient

Surveillance Fair or None or Good Good Good Good System deficient deficient None for None for None for Occurrence of Low or High or over five over three one to two Unknown clinical cases none unknown years years years Vaccination Very low None > 90% > 90% = or > 80% < 80% coverage 67 Viral activity None None None Yes Yes Unknown

Virus handling biosecu- Yes Yes Yes No No No rity

Entry prohibition / Yes Yes Yes Yes None None restriction Control of the entry of Yes Yes Yes Fair Deficient None animals Community Good Good Good Good Fair or none None participation

* Natural Barrier to or Prohibition/Restriction of the entry of animals and products.

Art. 2. This Administrative Ruling shall enter into force on the date of its publication.

LUIZ CARLOS DE OLIVEIRA ADMINISTRATIVE RULING No. 50 OF MAY 19, 1997

Published in the Official Gazette of May 23, 1997, Section 1, Page 10760

Modified by Administrative Ruling No. 4 of January 21, 2000

Approves the technical criteria for the classification of foot-and-mouth disease risk levels in the States.

THE SECRETARY FOR AGRICULTURE AND LIVE- (f) Occurrence of FMD clinical cases; STOCK HEALTH AND INSPECTION, by virtue of the (g) Vaccination coverage; powers vested in him under Art. 83 of this Office’s (h) Absence/presence of viral activity; Internal Regulations approved under Ministerial (i) Biosecurity pertaining to virus manipula- Administrative Ruling Nº. 319 of May 6, 1996, tion; Whereas there is a need to introduce appro- (j) Prohibition/restriction of the entry of ani- priate mechanisms for the planning of actions mals; under the National Program for the Eradication (k) Control of the entry of animals and ani- of Foot-and-Mouth Disease (PNEFA) in the States mal products; and so as to maintain or improve their sanitary status (l) Level of community participation. so far achieved; Art. 2. To establish the following six risk cat- Whereas risk analysis pursuant to the prin- egories: BR-D, or negligible risk; BR-1, or minimal ciples established under the WTO Agreement on risk; BR-2, or low risk; BR-3, or medium risk; BR- the Application of Sanitary and Phytosanitary 4, or high risk; and BR-N, or unknown or unclas- Measures and the International Zoosanitary Code sified risk, negligible risk being the lowest risk of of the World Organization for Animal Health (OIE) FMD transmission, while the other levels show a is the most appropriate method for defining zoo- gradually increasing risk. sanitary norms for the trade in animals and ani- Art. 3. The evaluation of each state and their mal products; classification according to their risk level will be Whereas the strategies for the regionaliza- done by this Secretariat’s Animal Health and In- 68 tion of the actions planned for FMD’s eradication spection Department and should indicate the are consistent with the technical criteria for zon- quality and the technical and operating capacity ing and regionalization under the International of their veterinary services, as well as their sani- Zoosanitary Code; tary status regarding foot-and-mouth disease. Whereas there is a need to establish zoo- Sole Paragraph. Classification shall be dynam- sanitary norms and procedures pertaining to the ic and may change as the risk situation changes ow- movement of live animals and animal products ing to the disease’s occurrence or to a change in susceptible of being vehicles of the FMD virus any of the risk factors pointed out above. among the States, Art. 4. The planning of sanitary actions RESOLVES: aimed at foot-and-mouth disease’s eradica- Art. 1. To approve technical criteria for clas- tion and the establishment of norms pertain- sifying the levels of FMD risk in States pursuant to ing to the interstate movement of foot-and- the following risk indicators or factors: mouth susceptible animals and their products (a) Program phase: prevention, eradication, and subproducts, as well as the procedures to or control; be adopted for reducing the risk of dissemi- (b) Geographical area covered by PNEFA; nation of the foot-and-mouth disease virus (c) Sanitary status of neighboring areas; throughout the states must be based on the (d) Veterinary health system; risk classification done by the Animal Health (e) Sanitary surveillance system; and Inspection Department. Art. 5. To approve the following Tables here- Annex III – Criteria for Classification of the to annexed: Sanitary Surveillance System. Annex I – FMD risk classification; Art. 6. This Administrative Ruling shall enter Annex II – Criteria for Classification of the into force on the day of its publication. Veterinary Health Care System; and ENIO ANTONIO MARQUES PEREIRA

ANNEX I

CLASSIFICATION OF FOOT-AND-MOUTH DISEASE RISK LEVELS Modified by Administrative Ruling No. 4 of January 21, 2000

ANNEX II

CRITERIA FOR CLASSIFICATION OF THE VETERINARY HEALTH CARE SYSTEM

No. of Veterinary Doctors HUMAN RESOURCES No. of Technical Assistants No. of Administrative Assistants Other categories Working status Job and salary structure HUMAN RESOURCES POLICY Training Motivation No. of Regional Offices STRUCTURE No. of Local Offices No. of vehicles 69 Average age VEHICLES Condition No. of state Associations COMMUNITY PARTICIPATION No. of local Associations Sufficient amount FINANCIAL RESOURCES Timeliness LEGISLATION Current To address outbreak MATERIALS AND EQUIPMENT Office Prompt attention MOBILIZATION CAPACITY Swift mobilization of human, IN EMERGENCIES physical, and financial resources

SANITARY EDUCATION — ANNEX III

CLASSIFICATION CRITERIA FOR THE SANITARY SURVEILLANCE SYSTEM

REGISTER OF ESTABLISHMENTS % of registered establishments No. of fixed checkpoints CONTROL OF THE ENTRY OF ANIMALS No. of mobile checkpoints No. of entry highways No. of mobile checkpoints CONTROL OF INTERNAL MOVEMENT No. of Animal Movement Movement Permits issued % of inspected properties VACCINATION INSPECTION No. of infraction bookings % of notifications by owners COMMUNITY PARTICIPATION No. of local Associations No. of inspected selling establishments VACCINE SALES INSPECTION No. of vaccine doses sold MATERIAL COLLECTION % of collection Telephone Fax COMMUNICATION Computers Radio INSPECTION OF EXPOSITIONS, FAIRS, Presence of veterinary services AUCTIONS, AND OTHER ANIMAL Inspection and control actions AGGLOMERATIONS Cleaning and disinfection Intervened 70 Interdiction ATTENTION TO Outbreaks Traceability Disinfection Perifocal vaccination Sanitary slaughter NORMATIVE INSTRUCTION No. 63 OF DECEMBER 17, 2008

Published in the Official Gazette of December 18, 2008, Section 1, Page 48

Approves the Guidelines for the Implementation of the Veterinary Surveillance System in the Foot-and-Mouth Disease High Surveillance Zones (ZAVs) established along the borders between the State of Mato Grosso do Sul and the Republics of Paraguay and Bolivia, pursuant to the Annex hereto.

THE MINISTER OF AGRICULTURE, LIVESTOCK, issued by the Animal and Plant Health and In- AND FOOD SUPPLY, by virtue of the powers vest- spection Secretariat through the Animal Health ed in him under Art. 87, Sole Paragraph, II of the Department, and with the specific guidelines Constitution, having in view the provisions of De- hereunder. cree No. 5741 of March 30, 2006; the Regulations Paragraph 4. Rural properties, producers, of the Animal Health and Inspection Service, ap- and livestock establishments located in the proved by Decree No. 24548 of July 3, 1934; Nor- ZAVs, which have foot-and-mouth susceptible mative Instruction No. 44 of October 2, 2007; and animals shall be specifically identified in the Proceeding No. 21000.010691/2008-95, state veterinary service’s register and informa- RESOLVES: tion system, which must be kept current and Art. 1. To approve the Guidelines for the made available when required for animal Implementation of the Veterinary Surveillance health actions and by Official Veterinary Servic- System in the Foot-and-Mouth Disease High Sur- es of the other states, as well as of the Republics veillance Zones (ZAVs) established along the bor- of Paraguay and Bolivia. der between the State of Mato Grosso do Sul and Paragraph 5.The individual identification the Republics of Paraguay and Bolivia, pursuant system referred to in the preceding Paragraph 4 to the Annex hereto. is mandatory and shall be introduced and con- Paragraph 1. The aforementioned ZAVs en- trolled by the state veterinary service, which, compass a strip of land approximately 15-km on the basis of technical evaluation, may em- wide belonging to the Municipalities of Porto ploy other existing systems, provided there is no 71 Murtinho, Caracol, Bela Vista, Antônio João, Ponta prejudice to the sanitary controls and procedures Porã, Aral Moreira, Coronel Sapucaia, Paranhos, adopted in the ZAVs. Sete Quedas, Japorã, Mundo Novo, Corumbá, and Paragraph 6. Rural properties encompassed Ladário in the State of Mato Grosso do Sul. by ZAVs and near their geographical boundaries Paragraph 2. The ZAVs’ boundaries shall be should be fully included in them. set on the basis of the geographical boundaries Art. 2. To authorize the Animal and Plant of rural properties situated in an approximately Health and Inspection Secretariat to issue com- 15-km wide strip beginning at the border and plementary norms consistently with the unfold- consisting preferentially of natural barriers or, in ing of the work in the High Surveillance Zones the absence of such, of specific elements that fa- established along the border between the state cilitate the identification of their boundaries and of Mato Grosso do Sul and the Republics of Para- permit better control of livestock undertakings guay and Bolivia. and veterinary surveillance actions. Art. 3. This Normative Instruction shall enter Paragraph 3. It is incumbent on the state vet- into force on the date of its publication. erinary service to define the ZAVs’ geographical Art. 4. SDA Normative Instructions No. 6 of boundaries and to execute the veterinary surveil- February 2008 and No. 19 of April 14, 2008 are lance actions defined in the technical manuals hereby revoked.

REINHOLD STEPHANES ANNEX

GUIDELINES FOR THE IMPLEMENTATION OF THE VETERINARY SURVEILLANCE SYSTEM IN THE FOOT-AND-MOUTH DISEASE HIGH SURVEILLANCE ZONES (ZAVs) ESTABLISHED ALONG THE BORDER BETWEEN THE STATE OF MATO GROSSO DO SUL AND THE REPUBLICS OF PARAGUAY AND BOLIVIA

Art. 1. Veterinary surveillance actions carried VIII – Caracol Municipality, Highway BR 384, out in the Foot-and-Mouth Disease High Surveil- Latitude 21.9997, Longitude 57.0176; lance Zones (ZAVs) shall follow MAPA’s general IX – Japorã Municipality, Route MS 386, Lati- guidelines, including the specific actions called tude 23.7566, Longitude 54.5882; for hereunder. X – Tacuru Municipality, Route MS 295, Lati- Art. 2. The state veterinary service shall tude 23.6584, Longitude 54.9095; maintain a structure consistent with veterinary XI – Mundo Novo Municipality, Highway BR surveillance actions, having in view the establish- 163, Latitude 24.0048, Longitude 54.3121; ment and maintenance of the following items in XII - Eldorado Municipality, Highway BR the ZAVs: 163, Latitude 23.7922, Longitude 54.2821; I – A local veterinary unit in each munici- XIII – Paranhos Municipality, Route MS 295, pality; Latitude 23.7413, Longitude 55.2526; II – A permanent staff of at least two veteri- XIV – Paranhos Municipality, Route MS 165, nary doctors per local veterinary unit; Latitude 23.6489, Longitude 55.3909; III – Fixed inspection checkpoints at entry XV – Ponta Porã Municipality, Route MS 164, locations; Latitude 21.977 [sic], Longitude 55.5453; IV – Mobile inspection teams; XVI – Ponta Porã Municipality, Route MS 386, V – Cartographic maps, both printed and in Latitude 22.6889; Longitude 55.6076; electronic form, showing the boundaries and the XVII – Ponta Porã Municipality, Highway BR identification of all rural properties located in the 463, Latitude 22.3658, Longitude 55.3356; ZAVs; these maps should be available at all offices XVIII – Porto Murtinho Municipality, Highway 72 serving the community; and BR 267, Latitude 21.7465, Longitude 57.5611; VI – Adequate communications and displace- XIX – Jardim Municipality, Highway BR 267, ment structure. Latitude 21.5521, Longitude 56.6048; Paragraph 1. The fixed inspection checkpoints XX – Sete Quedas Municipality, Route MS 160, shall be established at the following locations: Latitude 23.9609, Longitude 55.0038; I – Amambai Municipality, Route MS 289, XXI – Tacuru Municipality, Route MS 160, Lati- Latitude 23.1983, Longitude 55.2939; tude 23.8020, Longitude 55.0369; II – Amambai Municipality, Route MS 485, XXII – Corumbá Municipality, Jacadigo Road, Latitude 23.1030, Longitude55.2643; Latitude 19.0994, Longitude 57.8134; III – Antônio João Municipality, Route MS 384, XXIII – Corumbá Municipality, Assentamento Latitude 22.1133, Longitude 56.1664; Urucum Entrance, Latitude 19.1633, Longitude IV – Antônio João Municipality, Route MS 384, 57.6356; and Latitude 22.2784, Longitude 55.8439; XXIV – Corumbá Municipality, Forte Coimbra, V – Aral Moreira Municipality, Route 386, Latitude 19.3218, Longitude 57.5876. Latitude 22.8165, Longitude 55.3624; Paragraph 2. Any modification to the above VI – Bela Vista Municipality, Highway BR 060, list of fixed checkpoints shall be permitted only un- Latitude 22.0294, Longitude 56.5156; der approval by the Animal and Plant Health and VII – Bonito Municipality, Route MS 382, Lati- Inspection Secretariat, subject to technical opinion tude 21.0627, Longitude 56.7319; handed down by the state veterinary service. Art. 3. The state veterinary service shall es- applicable to regions of origin classified as BR-3 tablish and keep current the following in the ZAVs, (medium risk) for FMD or classified under a simi- without prejudice to other norms and guidelines lar risk category that may be adopted by MAPA, under the National Program for the Eradication and pursuant to Chapters VI and VII of Normative In- Prevention of Foot-and-Mouth Disease (PNEFA): struction No. 44 of October 2, 2007, according to I – A georeferenced register of all rural prop- the destination’s sanitary status. erties with animals susceptible to FMD; Paragraph 1. Beef ageing and boning and the II – Long-standing individual identification, procedures for inactivating the foot-and-mouth specific to the state veterinary service, to be ap- disease shall be waived if the beef comes from an plied to all cattle, buffalo and small ruminant establishment that has a Federal Inspection Ser- specimens; and vice unit; however, this requirement stands if the III – An official system of inspection and mon- destination is a foot-and-mouth disease free zone itoring of foot-and-mouth disease vaccination. without vaccination. Paragraph 1. At the ZAVs, a specific veterinary Paragraph 2. The serologic tests required for monitoring and surveillance system should be in- the movement of animals may, at the Agriculture troduced pursuant to PNEFA’s guidelines. and Livestock Office’s discretion, be replaced by Paragraph 2. Registers pertaining to rural other surveillance procedures capable of ensuring properties, rural producers, livestock establish- the protection of the sanitary status of the ani- ments, individual animal identification, and mals’ destination. movement of animals should be maintained at Paragraph 3. Irrespective of the destination the state veterinary service’s local veterinary units of the animals and animal products, transport for consultation and checking on the occasion of vehicles must have their cargo officially sealed inspections and audits. and must follow the routes established by the Paragraph 3. The systematic vaccination state veterinary service, which must obligatorily of cattle and buffalo should take into consider- include passage through one of the fixed check- ation the general guidelines established under points referred to under Art. 2 hereunder. Normative Instruction No. 44 of October 2, 2007, Paragraph 4. The Animal Movement and be carried out consistently with the Official Permits(GTAs) issued for the movement of cattle, Veterinary Service of the neighboring countries buffalo, or small ruminants leaving a ZAV must be involved, under approval of the Animal and Plant accompanied by a list of the individual animals 73 Health and Inspection Secretariat. transported. Paragraph 4. In the region along the border Paragraph 5. The period of quarantine at the between Corumbá and the Republics of Paraguay origin shall be waived in the case of cattle des- and Bolivia, in the stretches situated between the tined for immediate slaughter, and reduced to fif- lat 19º15’00.22” S and long 57º53’09.26 W geo- teen days on establishments that have no record graphical markers and the Porto Murtinho Mu- of the entry of animals susceptible to FMD in the nicipality boundary, and between the seat of the 30 days prior to their movement. Corumbá Municipality and the Mato Grosso do Sul Art. 5. Susceptible animals may enter ZAVs state line there will be no need to establish ZAVs only under prior authorization of the state veteri- in view of predominant geographical conditions, nary service, and must be promptly entered into low animal concentration, and scarcity of roads. the register and individual identification system However, rural properties located in the area cir- adopted in the destination zone. cumscribed by this Art. should be subjected to spe- Sole Paragraph. Under this Article’s provi- cific surveillance by the state veterinary service, sions, entry may be permitted only if the routes including the monitoring of FMD vaccination. established by the state veterinary service are Art. 4. The movement of and trade in ani- followed, including the obligatory passage mals and animal products under FMD risk from through one of the fixed checkpoints referred ZAVs shall be subject to the same requirements to in Art. 2 above. ADMINISTRATIVE RULING No. 53 OF NOVEMBER 23, 2007

Published in the Official Gazette of November 26, 2007, Section 1, Page 16 Republished on November 27, 2007

Recognizes and confirms the sanitary status of the States in regard to the foot-and-mouth disease.

THE MINISTER OF AGRICULTURE, LIVESTOCK, in any of the areas considered to be free of the AND FOOD SUPPLY, by virtue of the powers vest- disease shall imply the temporary suspension of ed in him under the provisions of Art. 2 of Decree the current status. No. 5741 of March 30, 2006, having in view the Paragraph 1. Suspension may apply to only provisions of Art. 71 of the Animal Health and part of the free area if the outbreak is circum- Inspection Service Regulations approved under scribed and if it is possible to establish a conten- Decree No. 24548 of July 3, 1934 and pursuant tion zone on which to concentrate all the cases so to Proceeding No. 21000.010424/2007-37, hereby as to reduce the disease’s impact to a minimum. resolves as follows: Paragraph 2. The previous sanitary status Art. 1. To recognize and confirm the sanitary shall be restored once the recommended sani- status of the States in regard to the foot-and- tary measures have been applied within the min- mouth disease, pursuant to the Annex hereto. imum deadline established for each case. Art. 2. The occasional occurrence of one or Art. 3. This Administrative Ruling shall enter more than one case of foot-and-mouth disease into force on the date of its publication.

REINHOLD STEPHANES

74 ANNEX

BRAZIL’S SANITARY STATUS IN REGARD TO THE FOOT-AND-MOUTH DISEASE 2007

Last foot-and- Sanitary Status States mouth disease Observations Recognition Acts occurrence record Free of foot-and- mouth disease Santa Catarina December 1993 The entire territory MAPA Administrative Ruling without vaccination 153/2000

Acre June 1999 The entire territory MAPA Administrative Ruling No. 14/2005 Municipalities of Amazonas September 2004 Boca do Acre and MAPA Administrative Ruling No. 14/2005 Guajará Bahia May 1997 The entire territory* MAPA Administrative Ruling No. 14/2005 Federal District May 1993 The entire territory MAPA Administrative Ruling No. 618/1999 Espírito Santo April 1996 The entire territory MAPA Administrative Ruling No. 14/2005 Goiás August 1995 The entire territory MAPA Administrative Ruling No. 618/1999 Free of foot-and- Mato Grosso January 1996 The entire territory MAPA Administrative Ruling No. 618/1999 mouth disease Mato Grosso do Sul April 2006 The entire territory MAPA Administrative Ruling No. 39/2007 with vaccination Minas Gerais May 1996 The entire territory MAPA Administrative Ruling No. 618/1999 Center-South Region. Municipalities listed Pará June 2004 MAPA Administrative Ruling No. 43/2006 under Administrative Ruling No. 43/2006 Paraná February 2006 The entire territory MAPA Administrative Ruling A No. 61/2006 Rio de Janeiro March 1997 The entire territory MAPA Administrative Ruling No. 14/2005 Rio Grande do Sul May 2001 The entire territory MAPA Administrative Ruling No. 14/2005 Rondônia February 1999 The entire territory* MAPA Administrative Ruling No. 543/2002 São Paulo March 1996 The entire territory MAPA Administrative Ruling No. 618/1999 Sergipe September 1995 The entire territory MAPA Administrative Ruling No. 14/2005 75 Tocantins May 1997 The entire territory* MAPA Administrative Ruling No. 14/2005

Alagoas September 1999 The entire territory Without recognition Amapá October 1999 The entire territory Without recognition Amazonas September 2004 Except for the Without recognition Municipalities of Boca do Acre and Guajará States that do Ceará April 1997 The entire territory Without recognition not present the conditions Maranhão August 2001 The entire territory Without recognition required for Pará June 2004 Northern Region. Without recognition inclusion in one Municipalities not of the two listed under IN SDA categories above Nº. 25/200725/2007 Paraíba October 2000 The entire territory Without recognition Pernambuco February 1998 The entire territory Without recognition Piauí February 1997 The entire territory Without recognition Rio Grande do August 2000 The entire territory Without recognition Norte Roraima June 2001 The entire territory Without recognition * Except for buffer zone NORMATIVE INSTRUCTION No. 44 OF OCTOBER 2, 2007

Published in the Official Gazette of October 3, 2007 Section 1, Page 2

Approves the general guidelines for Foot-and-Mouth Eradication and Prevention, pursuant to Annexes I, II, III, and IV hereto, to be followed throughout the National Territory, with a view to the implementation of the National Program for the Eradication and Prevention of Foot-and-Mouth Disease (PNEFA), as established by the Agriculture and Livestock Health Care Unified System.

THE MINISTER OF AGRICULTURE, LIVESTOCK, as established by the Agriculture and Livestock AND FOOD SUPPLY, by virtue of the powers vested Health Care Unified System. in him under Art. 2 of Decree No. 5741 of March Art. 2. This Normative Instruction shall enter 30, 2006, having in view the provisions of said into force on the date of its publication. Decree and of Arts. 10 and 71 of the Regulations Art. 3. SDA Administrative Ruling No. 11 of of the Animal Health and Inspection Service, ap- November 3, 1983; Ministerial Ruling No. 121 of proved by Decree No. 24548 of July 3, 1934; and March 29, 1993; SDA Administrative Ruling No. Proceeding No. 21000.0045/2007-81 185 of December 1, 1993; Administrative Ruling RESOLVES: No. 162, I a, b, c, d, and e of October 18, 1994; Ad- Art. 1. To approve the general guidelines ministrative Ruling No. 82 of June 28, 1996; SDA for Foot-and-Mouth Eradication and Pre- Normative Instruction No. 11 of March 13, 2001; vention, pursuant to Annexes I, II, III, and IV SDA Normative Instruction No. 47 of September hereto, to be observed throughout the National 26, 2001; SDA Normative Instruction No. 5 of Territory, with a view to the implementation of January 17, 2003; Administrative Ruling No. 40 of the National Program for the Eradication and July 14, 2003; and SDA Normative Instruction No. Prevention of Foot-and-Mouth Disease (PNEFA), 82 of November 20, 2003 are hereby revoked.

REINHOLD STEPHANES

76 ANNEX I

GENERAL GUIDELINES ON THE ERADICATION AND PREVENTION OF FOOT-AND-MOUTH DISEASE

CHAPTER I I – Susceptible animals: cattle, buffalo, sheep, goats, pigs, wild ruminants, and other DEFINITIONS animals in which infection has been scientifically proven; Art. 1. The National Program for the Eradica- II – Sanitary protection area: geographical tion of Foot-and-Mouth Disease (PNEFA) uses the area established around FMD outbreak under the technical and scientific definitions established by strategy for containment and elimination of the international organizations and institutions of infectious agent. The definition of the geographi- which Brazil is a signatory, and especially those cal boundaries is incumbent on the Official Veteri- established by the World Organization for Animal nary Service, which should take into account the Health (OIE). disease’s epidemiological characteristics, the pre- Sole Paragraph. For the purposes of this Nor- dominant livestock production systems, and the mative Instruction, the following definitions apply: existing communication structure and road system as well as natural barriers capable of preventing any infectious matter; the disease’s dissemination. Such an area shall be c) Excreta, tissue, organ, or any other mate- established by a specific act that must specify the rial that can be sent to a specialized laboratory sanitary actions to be carried out. A sanitary protec- for diagnostic. tion area should encompass the following: VI – In natura offal: organs and viscera of a) A perifocal area: an area immediately susceptible animals, not subjected to any physi- adjacent to the FMD outbreak, covering at least cal or chemical treatment; the rural properties adjacent to the outbreak in VII – Contingency Plan: document setting question. For its delimitation, a three-kilometer forth the principles, strategies, procedures, and radius may be drawn taking as starting point the responsibilities pertaining to a veterinary emer- geographical limits of the confirmed outbreak; gency, geared to training and to organizing, guid- b) A surveillance area: an area immediately ing, facilitating, expediting, and standardizing adjacent to the perifocal area. For its delimita- the requisite actions for rapid response aimed at tion, rural properties situated within a seven-ki- controlling and eliminating the disease; lometer radius from the boundaries of the perifo- VIII – Action Plan: a part of the Contingen- cal area may be considered; and cy Plan that establishes specific procedures for c) A buffer area: an area immediately adjacent the investigation of suspected cases of vesicular to the surveillance area and whose limits are the disease and for addressing foot-and-mouth dis- outermost boundaries of the surveillance area. In ease outbreak; support of its delimitation, rural properties located IX – Sanitary slaughter: elimination of all within a radius of up to fifteen kilometer from the animals that, in the judgment of the Official Vet- boundaries of the surveillance area. erinary Service that pose a risk of spreading or III – Infectious vesicular diseases: a set of maintaining the biologic agent, followed by de- transmissible diseases characterized mainly by struction of the carcasses by incineration, burial fever and limping and excessive salivation syn- or any other process that ensures the elimina- drome caused by vesicles or vesicular lesions in tion of the infectious agent and stops the infec- the mouth, muzzle, or feet, which may also occur tion’s propagation, followed in turn by cleaning in the udder region. This category includes foot- and disinfection; and-mouth disease, vesicular stomatitis and oth- X – Official Veterinary Service: government er diseases that may be confused with them and animal health and inspection agency; 77 that may present ulcerating or erosive lesions as XI – Veterinary emergency system: a set of they progress; resources, structures, and procedures whose ob- IV – Veterinary emergency: a condition jective is to develop the capacity for rapid detec- caused by outbreak of diseases with an epidemic tion of and prompt response to the occurrence potential to entail serious sanitary, social, and of diseases, and for their control and eradica- economic consequences, which may compromise tion. It includes the preparation of contingency domestic and international trade, food security, and action plans. or public health, and which require immediate XII – Types of cases covered by the investiga- control or elimination actions, so as to reestab- tion of vesicular diseases: lish the previous sanitary status as soon as pos- a) Suspected case of vesicular disease: noti- sible and at the best cost/benefit ratio; fication by third parties to the Official Veterinary V – Pathogenic material: material posing Service, indicating the possibility of one or more FMD risk, collected from confirmed cases of in- than one animal with clinical signs consistent fectious vesicular disease or from any FMD sus- with infectious vesicular disease; ceptible animal in the infected zone, including b) Confirmed case of vesicular disease: cer- the following: tification by the Official Veterinary Service of a) Samples of foot-and-mouth disease virus; the existence of animals showing clinical signs b) Samples of blood serum, total blood, or consistent with infectious vesicular diseases and requiring the prompt adoption of bios- logic unit is incumbent on the Official Veterinary ecurity measures and steps toward laboratory Service, which should base its determination on diagnostic; technical analyses and field assessment. If more c) Dismissed case of vesicular disease: any than one rural property is involved, consideration suspected case of vesicular disease that has should be given to geographic continuity. been investigated by the Official Veterinary XIV – Epidemiologic link: expression used Service, which has determined that the clinical to establish the possibility of transmission of the signs are not consistent with infectious vesicu- infectious agent between confirmed cases of dis- lar disease; and eased animals and susceptible animals, whether d) Case or outbreak of FMD: occurrence or not these are located on the same livestock at some epidemiologic unit of at least on case establishment. It may be established through that meets one or more than one of the fol- the movement of animals, geographic proximity lowing criteria: allowing contact between diseased and suscep- 1. Isolation and identification of the foot- tible animals, or the presence of other elements and-mouth disease virus in samples from sus- capable of serving as carriers for the infectious ceptible animals showing or not clinical signs of agent. Characterization of the epidemiologic link the disease or in samples of products from these is incumbent on the Official Veterinary Service, animals; and should be based on technical analyses and 2. Detection of the specific FMD virus anti- field assessments; gen in samples from confirmed cases of vesicular XV – Zone: a concept introduced by the disease or from animals that may have had direct OIE and adopted in PNEFA’s strategies to mean or indirect contact with the causing agent; a clearly circumscribed part of a country with 3. Existence of an epidemiologic link to an- an animal subpopulation in a particular health other FMD outbreak and occurrence of at least condition for a specific animal disease. As regards one of the following conditions: foot-and-mouth disease, OIE’s Sanitary Terrestrial Occurrence of one or more than one con- Animal Health Code recognizes the following four firmed case of vesicular disease; zones: Detection of antibodies against nonstruc- a) Free zone, with or without vaccination, re- tural or noncapsidial proteins of the FMD virus in fers to a geographical space that has been certi- animals not vaccinated against this disease; fied by the Ministry of Agriculture, Livestock, and 78 Detection of antibodies against nonstructur- Food Supply (MAPA) as meeting the following al or noncapsidial proteins of the foot-and-mouth conditions: no occurrence of outbreak and viral disease virus, and the suspicion of infection can- circulation under an established timeframe; exis- not be dismissed by epidemiologic investigation; tence of an adequate animal health surveillance e) Dismissed case of FMD: any confirmed system; existence of a consistent legal framework; case or outbreak of vesicular disease that does and existence of an adequate Official Veterinary not meet the confirmation criteria for FMD; Service structure; XIII – Epidemiologic unit: a group of animals b) Buffer zone, a geographical space estab- with similar probability of exposure to the FMD lished to protect the health condition of a free virus. Depending on the epidemiologic relations zone herds vis-à-vis animals and animal products established and on the size of the involved rural and subproducts from another country or from properties, an epidemiologic unit may consist of a zone with a different sanitary status, through one rural property, a group of rural properties the adoption of measures based on the disease’s (e.g. rural settlements or small villages), part of a epidemiologic characteristics, so as to prevent rural property, or any other kind of establishment the introduction of the pathogenic agent. These with a concentration of animals susceptible to the measures may include vaccination, control of the disease (e.g., on exposition grounds or in auction movement of animals, and enhanced surveil- facilities). The determination of an epidemio- lance of the disease; c) Infected zone, a country’s geographical of products and subproducts thereof; space that lack the requisite conditions to be rec- i) implementation of sanitary education and ognized as a free zone with or without vaccina- public relations programs; tion; and j) organization and consolidation of commu- d) Containment zone, a geographical space nity participation through the establishment and established around infected or supposedly infect- maintenance of state and local animal health ed livestock establishments, whose extent is deter- commissions; mined on the basis of epidemiologic factors and k) maintenance of an adequate supply of investigation results, where control measures are foot-and-mouth disease vaccines produced un- taken to prevent the infection from spreading. der MAPA’s control; l) control of FMD vaccine’s marketing and CHAPTER II application procedures; and m) introduction and maintenance of a PNEFA’S FUNDAMENTS AND STRATEGIES veterinary emergency system with capacity for immediate notification and prompt response Art. 2. PNEFA’s objectives are the eradica- vis-à-vis suspected and conformed cases of ve- tion of the FMD from the entire National Terri- sicular disease. tory and the preservation of this sanitary status II – Priority measures in free zones: through the introduction and implementation a) Strengthening of the prevention system, of a sanitary surveillance system underpinned including the introduction of ongoing clinical by the Official Veterinary Service’s structures and and scientific analyses to identify vulnerabilities by community participation. These objectives and guide surveillance and inspection activities; have been incorporated into the Hemispheric b) Introduction of normative and technical Plan for the Eradication of Foot-and-Mouth Dis- procedures pertaining to the sanitary slaughter ease, which seeks to eliminate the disease in all of animals and the destruction of animal prod- of South America. ucts under FMD risk, whose entry was irregular or Art. 3. PNEFA’s execution is based on scien- without proof of origin; tific criteria and on international guidelines on c) Adoption of procedures for monitoring the combating the disease, and relies on the sharing health condition of susceptible herds; of responsibilities between the public and the d) Establishment and maintenance of pri- 79 private sectors. Its strategies encompass the fol- vate or public financial funds to support the vet- lowing: erinary emergency system; and I – General and common measures, such as: e) Implementation, in free zones with vac- a) maintenance and strengthening of the Of- cination, of strategies and a timetable for sus- ficial Veterinary Services’ structures; pension of the obligation of vaccination against b) register of livestock sector’s establish- FMD. ments; III. Priority measures in infected zones: c) adoption of acts to support PNEFA’s oper- a) Strengthening of the animal health sur- ating measures, including corrective actions; veillance system, taking into consideration the d) establishment of Official Veterinary Ser- introduction of Official Veterinary Services; vice supervision and auditing systems; b) Performance of analyses and technical e) modernization of the epidemiologic infor- evaluations for epidemiologic characterization mation system; and assessment of the agricultural and livestock f) strengthening of laboratory diagnostic productive conditions of the involved regions structures; and for defining viral agent eradication strate- g) strengthening of human resources train- gies; and ing programs; c) Reinforcement of the participation by oth- h) control of the movement of animals and er public and private sectors. CHAPTER III Art. 5. The development and maintenance of FMD epidemiologic surveillance involves the ADDRESSING SUSPECTED VESICULAR following actions: DISEASE CASES AND FOOT-AND-MOUTH I – Maintenance of an appropriate adminis- DISEASE outbreaks trative structure for veterinary emergency cases, as part of the contingency plan; Art. 4. The notification of infectious vesicu- II – Immediate notification of suspected lar diseases is compulsory. All veterinary doctors, cases of vesicular disease and prompt response rural producers, animal carriers, and profession- to confirmed cases; als working in official or private veterinary labo- III – Drafting of an action plan for attention ratories and at veterinary teaching or research to and epidemiologic investigation of confirmed institutions who have knowledge of suspected cases of vesicular disease and FMD outbreaks; cases of vesicular diseases are under the obliga- IV – Offering of training and doing simulation of reporting the fact to the Official Veterinary tions for the action plan’s execution; Service within 24 hours from the moment they V – Development of adequate operating ca- acquired knowledge of the suspected cases. pacity, with emphasis on diagnostic laboratories; Paragraph 1. Should the notification’s author VI – Drafting of acts and disciplining proce- own or be in charge of the livestock establish- dures with a view to the participation of other ment with suspected cases of vesicular disease, government and private sectors in prompt re- he should hold the movement of animals and of sponse; and animal products and subproducts, pending au- VII – Development of the capacity for applying thorization from the Official Veterinary Service. all the requisite resources to contain the disease’s Paragraph 2. Suspected cases must be noti- spread, including personnel, equipment, financial fied in person or by any available means of com- resources, and government measures to mitigate munication, the right to anonymity being safe- the attendant economic and social impact. guarded. Paragraph 1. MAPA is responsible for coordi- Paragraph 3. All notifications of suspected nating the introduction and management of the cases of vesicular disease must be entered into veterinary emergency system. the records by the Official Veterinary Service, Paragraph 2. It shall be incumbent on the which must act on them within 12 hours from Official Veterinary Service to adopt all the recom- 80 their submission, pursuant to the action plan ad- mendations under the action plan on vesicular opted by the Official Veterinary Service. diseases. Paragraph 4. Noncompliance with the provi- Art. 6. The recording and communication of sions of this Article’s heading shall be duly inves- suspected and confirmed cases of vesicular disease tigated by the Official Veterinary Service, which should meticulously follow the communication shall bring charges against the infringer before system established and coordinated by MAPA. the Public Attorney’s Office, if appropriate. Art. 7. The confirmation of a case of vesicu- Paragraph 5. Should the infringer be a vet- lar disease entails the prompt adoption of sani- erinary doctor, in addition to following the pro- tary measures to identify and contain the causing cedure referred to in the preceding Paragraph 4, agent. In such case, the epidemiologic investiga- the Official Veterinary Service shall lodge formal tion should be carried further to determine the charges before the Regional Council of Veteri- origin and extent of the health problem. Immedi- nary Medicine; ate actions include the following: Paragraph 6. The Official Veterinary Service I – The entry into the records and communi- in the States is responsible for waging education- cation of the occurrence to the higher authorities al, awareness-raising campaigns informing the by the filled-out pertinent form and through the community and preparing it for prompt notifica- communication channels defined by MAPA; tion of suspected cases of vesicular disease. II – Definition and interdiction of the epidemiologic unit with confirmed cases of vesicular Art. 9. When there is no confirmation of a disease; outbreak of FMD or of another disease, whether III – Collection of material for laboratory di- exotic or eradicated in the country, the interdic- agnostic, accompanied by clinical and epidemio- tion referred to in the preceding Arts. 7 and 8 may logic evaluation; be suspended, provided this is done according to IV – An initial epidemiologic investigation, the technical recommendations for each case. taking into account the analysis of the movement Art. 10. The confirmation of a foot-and- of susceptible animals; and mouth disease outbreak shall entail the decla- V – Temporary suspension of the movement ration of a veterinary emergency in accordance of risk animals and products from rural establish- with the contingency and action plans. ments adjacent to or having an epidemiologic Paragraph 1. MAPA shall define and coordi- link to the epidemiologic unit where cases of ve- nate the actions to be undertaken, taking into ac- sicular disease have been confirmed. count the sanitary status of the region involved, Art. 8. Interdiction, as provided for in the the assessment of the risk of dissemination of the preceding Art. 7, involves the following: viral agent, the evaluation of the region’s vulner- I - Entering the interdiction into the records ability and receptivity, and the local veterinary and informing accordingly the rural producers, or service’s response capacity, as well as the possible their proxies, who own livestock establishments economic and social consequences. Actions may in the epidemiologic unit at stake, and giving include sanitary slaughter, emergency vaccina- them orientation about the requisite biosecurity tion, and interdiction measures. measures to be adopted; and Paragraph 2. Pending the definition and II – Prohibition of the exit of animals, wheth- delimitation of the sanitary protection areas er or not susceptible to the disease, and of any around the confirmed foot-and-mouth disease other products or materials likely to carry the vi- outbreak, MAPA shall determine the interdiction ral agent, as well as prohibition of the entry and of a larger security area, which may encompass exit of unauthorized vehicles or persons. municipalities, states, or some other geographic Paragraph 1. If it is not possible to store milk division and which may be necessary to prevent at the epidemiologic unit, the Official Veterinary the infectious agent from spreading to other re- Service shall decide in favor of the on-site destruc- gions of the country. tion of milk and provide orientation accordingly, or Art. 11. The confirmation of vesicular dis- 81 authorize its transportation under official control ease by the veterinary inspection service at by an appropriate means of transportation to the slaughterhouses during ante- and post-mortem nearest location, where procedures will be under- inspections must be promptly reported to the Of- taken to ensure the destruction of the viral agent. ficial Veterinary Service of the involved state, as Paragraph 2. The prohibitions hereunder the case may be. may be replaced by biosecurity measures defined Paragraph 1. Irrespective of the scope of the by the Official Veterinary Service, provided the veterinary inspection service at the slaughter- zoosanitary measures to prevent the spread of house, the sanitary measures and technical pro- the viral agent are adopted. cedures established by MAPA must be applied. Paragraph 3. For the purposes of investigation Paragraph 2. The sale of meat, products, and of suspected cases of vesicular diseases, control of subproducts obtained from slaughtering shall be outbreaks, monitoring, or surveys for assessing viral suspended until the Official Veterinary Service circulation, or of any other activity of importance makes a decision on their destination. for the disease’s eradication, the Official Veterinary Art. 12. Should an infectious vesicular dis- Service may temporarily suspend foot-and-mouth ease be confirmed on the premises of expositions, disease vaccination and the movement of animals fairs, auctions, and other animal agglomerations, of the livestock establishment involved or of re- the provisions under Arts. 7 and 8 hereunder gions considered at sanitary risk. must be complied with, as applicable. CHAPTER IV food leftovers from them for feeding animals; V – Prohibition of the use, for feeding pigs, RECOGNITION AND MAINTENANCE OF of food leftovers from any origin, except if sub- FOOT-AND-MOUTH DISEASE FREE ZONES jected to thermal treatment to ensure the inactivation of the FMD virus; Art. 13. The recognition and maintenance of VI – Identification and monitoring of likely FMD free zones in the country and the restoring points of entry of animals, products, and sub- of sanitary status after reintroduction of the viral products in noncompliance with this Normative agent follow OIE’s guidelines. Instruction. Paragraph 1. Conduction of the process of VII – Specific identification in the Official Vet- recognition of a foot-and-mouth disease free erinary Service’s register of establishments that zone with or without vaccination is incumbent pose greater risk of introduction of the FMD virus; on MAPA and has the following stages: VIII – Specific identification of rural produc- I – Assessment, through supervision and au- ers that own livestock establishments in other dits by MAPA, of compliance with the requisite states, or foreign countries; technical and structural conditions; IX – Intensification of epidemiologic surveil- II – National declaration, issued by MAPA, of lance of livestock establishments, with priority recognition of the area involved as a foot-and- attention to the establishments referred to in the mouth disease free zone, with or without vacci- preceding VII and VIII items; and nation, based on MAPA’s favorable opinion; and X – Establishment and maintenance of mo- III – Submission of the Brazil’s technically bile inspection teams. supported application to the OIE, requesting the Paragraph 1. All animals susceptible to FMD, international recognition of a foot-and-mouth their products and subproducts, and any materi- disease free zone with or without vaccination. als, substances, or any other veterinary product Paragraph 2. To be classified as a foot-and- likely to carry the viral agent that enter free zones mouth disease free zone or as a buffer zone, a with or without vaccination in noncompliance state, or part thereof must fall at least into cat- with this Normative Instruction shall be sent to egory BR-3 (medium risk) regarding foot-and- sanitary slaughter or to sacrifice and destruction. mouth disease or into another risk category simi- Paragraph 2. At the Official Veterinary Ser- lar to another eventually adopted by MAPA. vice’s discretion, the products and subproducts 82 Art. 14. The maintenance of the sanitary sta- derived from sanitary slaughter or the seizure tus in FMD free zones requires the ongoing car- referred to under the preceding Paragraph 1 may rying out of epidemiologic surveillance activities be destined for consumption, provided public encompassing the following elements, without health and animal health are safeguarded. prejudice of other MAPA norms and procedures: Paragraph 3. Leftovers of food transported I – Control at interstate, port, airport, special or consumed on air, sea, river, or land travel shall customs, duty-free shop, landing strip, highway, be destroyed under Official Veterinary Service and colis posteaux entry checkpoints, including supervision by a method and at a location previ- passenger baggage inspection; ously approved by MAPA. II – Permission for the entry of animals, products, and subproducts presenting FMD risk only CHAPTER V after evaluation by the Official Veterinary Service; III – Prohibition of holding and manipulat- VACCINATION AGAINST FOOT-AND- ing whole FMD virus, except at institutions with MOUTH DISEASE an adequate biosecurity level and officially approved by MAPA; Art. 15. Only foot-and-mouth disease vac- IV – Prohibition of keeping animals at dump cines registered with and controlled by MAPA yards or on sanitary landfills, and of removing may be sold and used in the country. Paragraph 1. Registration shall be accorded b) Semestral vaccination of animals up to 24 solely to inactivated vaccines approved by the Of- months of age, and annual vaccination of animals ficial Veterinary Service. over 24 months of age, including or not booster Paragraph 2. The virus strains to be used in vaccination of animals up to 12 months of age, vaccines shall be defined by the Official Veteri- in 30-day stages. This strategy shall be adopted nary Service, based on assessment of the prevail- in states where the rural properties register has ing epidemiologic situation. been consolidated and where semestral vaccina- Paragraph 3. At the Official Veterinary Ser- tion has been done for at least two consecutive vice’s discretion, vaccines with specific character- years and overall vaccination indicators exceed istics to be used in risk areas and risk situations 80 percent; may be produced. c) Annual vaccination of all animals in 45- Art. 16. It shall be incumbent on the Offi- 60-day stages in regions where geographic char- cial Veterinary Service to inspect and control all acteristics permit the management of livestock phases of production, marketing, distribution, establishments only during a limited period of transport, and use of the foot-and-mouth disease the year; and vaccine as well as its discarding. d) Other vaccination strategies may be ad- Paragraph 1. Distributors or sellers must opted after MAPA’s appreciation. abide by the determinations of the Official Vet- IV – Once the vaccination stages have been erinary Service regarding the conservation, sale, defined, the Official Veterinary Services of the and control of foot-and-mouth disease vaccines. States will regulate and publicize the established Paragraph 2. Foot-and-mouth disease vac- procedures for their respective jurisdiction; cines may leave a selling establishment solely V – Any postponement or anticipation of under conditions that permit the maintenance vaccination stages must be approved by MAPA, of their temperature during transportation to a on the basis of a request supported by a techni- rural property. cal opinion issued by the interested Official Vet- Art. 17. The strategies for vaccination against erinary Service. FMD shall be defined by the Official Veterinary Paragraph 1. Foot-and-mouth disease vac- Service in accordance with the epidemiologic cination is incumbent on rural producers, who status of each state, zone or other geographical must provide proof of purchase of vaccines in a areas, consistently with the following: quantity consistent with their livestock establish- 83 I – The periods and the duration of the ment, and report their application according to systematic vaccination stages shall be defined the prescribed timetable and pursuant to proce- by MAPA, based on a technical proposal of the dures defined by the Official Veterinary Service. Official Veterinary Service in the states, drafted Paragraph 2. The Official Veterinary Services after evaluation of the region’s predominant of the States may accompany foot-and-mouth geographic and agricultural and livestock char- disease vaccination at any livestock establish- acteristics; ment located within their jurisdiction and may II – The systematic, mandatory vaccination also assume the task of purchasing or of applying in areas defined by MAPA shall be done on cattle the vaccine in risk areas or in other livestock es- and buffalo of all ages. The vaccination of goats, tablishments deemed of strategic importance. sheep, pigs, and other susceptible species is pro- Paragraph 3. The vaccination stages in place hibited, save in special situations, with MAPA’s until the date of publication of this Normative In- approval. struction shall remain in force, and any modifica- III – The following strategies of systematic, tion thereof must be approved by MAPA. mandatory vaccination of cattle and buffalo are Paragraph 4. At MAPA’s discretion, and as an recognized: exceptional measure, vaccination other than in a) Semestral vaccination of all animals in 30- the prescribed stages may be authorized. day stages; Paragraph 5. The Official Veterinary Service of the States shall prepare and submit to MAPA sessment of the attendant risks, and the infringer a report on foot-and-mouth disease vaccination shall be subjected to the sanctions and penalties activities, in accordance with MAPA’s guidelines, called for under the legislation of said state. within 30 days of the stage’s end. Paragraph 3. Any cargo of foot-and-mouth Paragraph 6. The Official Veterinary Service, susceptible animals that has been sealed by the under MAPA’s coordination, shall undertake epi- Official Veterinary Service at the origin according demiologic studies with a view to stopping sys- to the provisions hereunder may be unsealed only tematic foot-and-mouth disease vaccination. under Official Veterinary Service supervision. Art. 18. It shall be incumbent on the Offi- Paragraph 4. If the travel time exceeds 12 cial Veterinary Service of the States to inspect the hours on the road, an intermediate stop must be sale, distribution, and application of the vaccine designated beforehand, where the animals may against foot-and-mouth disease; inspection may rest and be fed. In this case, the cargo seal may be be done through random sampling consistently broken and the cargo must be sealed again under with parameters defined by MAPA. the supervision of the Official Veterinary Service Paragraph 1. In foot-and-mouth disease free on site, and the number of the new seal must be zones, dairy establishments may receive fresh entered into the Animal Movement Permit. milk solely from livestock establishments whose Art. 20. The issuance of the Animal Move- producers can show proof that vaccination has ment Permit for the movement of cattle and been done. buffalo from a state, as the case may be, or from Paragraph 2. In areas where vaccination is a region where foot-and-mouth disease vaccina- mandatory, dairy establishments may receive tion is mandatory must take into account the fol- fresh milk from livestock establishments whose lowing requirements, without prejudice to other producer can provide proof that vaccination has norms in force: been done. I – Compliance with the following timetable as of the date of the last vaccination: CHAPTER VI a) Fifteen days for animals that have been vaccinated once; CONTROL AND INSPECTION OF THE b) Seven days for animals that have been MOVEMENT OF ANIMALS SUSCEPTIBLE vaccinated twice; TO FOOT-AND-MOUTH DISEASE c) Any time after the third vaccination. 84 II – During the stages of foot-and-mouth Section I disease vaccination, the animals may be moved General considerations only after having received the vaccine corre- Art. 19. Any movement of foot-and-mouth sponding to the scheduled stage, in accordance susceptible animals requires an Animal Move- with the timetable referred to in the preceding ment Permit (GTA) and other documents estab- item I, save when they are destined for immedi- lished by the Official Veterinary Service according ate slaughter; to current norms. III – During the vaccination stage and up to Paragraph 1. The Animal Movement Permit 60 days after it ends, animals destined for imme- for the movement of cattle, buffalo, sheep, and diate slaughter are exempted from the manda- goats may be issued solely by the Official Veteri- tory foot-and-mouth disease vaccination; nary Service. IV – Animals over three months of age can- Paragraph 2. Any cargo of foot-and-mouth not be moved without proof that they have been susceptible animals that is in noncompliance with vaccinated at least once against foot-and-mouth the provisions hereunder shall be seized and des- disease; tined for sanitary slaughter or for other purpose V – Animals from regions where the foot-and- determined by the Official Veterinary Service of mouth disease vaccination strategy described un- the involved state, as the case may be, after as- der Art. 17, III c hereunder is applied, which are destined for participation in expositions, fairs, procedures at the origin; auctions, and other animal conglomerations in III – The Official Veterinary Service at the regions where foot-and-mouth disease vaccina- animals’ origin shall notify the Official Veteri- tion is mandatory must be accompanied by proof nary Service at the destination of the result of that they have received at least two vaccinations the evaluation and the beginning of the requisite against the disease, the last of which must have zoosanitary procedures; been applied no more than six months prior to IV – After compliance with the established the event. zoosanitary requirements, the Official Veterinary VI – At the discretion of the Official Veteri- Service at the animals’ origin shall notify the Of- nary Service, which will take into consideration ficial Veterinary Service at the destination accord- the foot-and-mouth disease epidemiologic sta- ingly, so that the latter may issue the authoriza- tus of the region in question, the participation tion for the entry of the animals into the region of foot-and-mouth susceptible animals in ex- in question, in accordance with the model form positions, fairs, auctions and other animal con- shown in Annex III hereto; and glomerations may be temporarily suspended at V – With the authorization issued by the Of- localities posing a risk of spreading the disease, ficial Veterinary Service of the animals’ destina- or subjected to complementary sanitary norms, tion state in hand, the Official Veterinary Service which may include booster vaccination against at the origin may authorize the issuance of the foot-and-mouth disease; requisite Animal Movement Permit, which must VII – The holding of expositions, fairs, auc- be accompanied by a zoosanitary certificate, in tions, and other animal conglomerations in re- accordance with the model form shown in Annex gions whose geographic characteristics permit IV hereto, which in turn must accompany the ani- the management of livestock establishments mals in question during the entire travel period. only during a limited period of the year must be Copies of the aforementioned documents must subjected to specific norms established by the Of- be forwarded to the Official Veterinary Service at ficial Veterinary Service of the states, as the case the destination. may be, after MAPA’s approval. Paragraph 1. The coordination of the pro- Art. 21. The entry of foot-and-mouth sus- cedures referred to hereunder is incumbent on ceptible animals into free zones, buffer zones, or MAPA’s Federal Agriculture Superintendence in states, which have been classified at least under the states, as the case may be, which should have 85 the BR-3 category (medium risk) for foot-and- the support and participation of the respective mouth disease or under any similar category Official Veterinary Services. eventually adopted by MAPA is subject to com- Paragraph 2. The documents described in pliance with the specific sanitary requirements the preceding must be issued according to the referred to in Sections II-IV hereunder, in accor- forms shown in Annexes II-IV hereto and should dance with the following procedures: bear, if applicable, the logo of the state or Federal I – The party interested in the entry of ani- District’s Official Veterinary Service. mals into the regions in question must submit Paragraph 3. The entry of foot-and- an application to the Official Veterinary Service mouth susceptible animals into free zones, of the destination state, in accordance with the buffer zones, or states, which have been clas- model form shown in Annex II hereto; sified at least under the BR-3 category (medi- II – The Official Veterinary Service at the um risk) for foot-and-mouth disease or under animals’ destination, after verifying the appropri- any similar category eventually adopted by ateness of the request in light of current norms, MAPA should be restricted to specific routes shall notify the Official Veterinary Service at the defined by MAPA, based on reasoned propos- origin accordingly, requesting it to check the in- als from the Official Veterinary Service of the formation submitted and to consider the feasibil- involved states. ity of the execution of the requisite zoosanitary Art. 22. If, among the zoosanitary procedures described in Sections II-IV hereunder, the isolation another foot-and-mouth disease free zone with- of animals is required, this can be done on the out vaccination, which are transported in sealed establishment of origin, provided the animals re- vehicles, while the other procedures referred to main together and separated from the other foot- under Art. 25 above shall be waived; and-mouth disease susceptible animals on the es- II – Sheep, goats, pigs, and other foot-and- tablishment, during the entire evaluation period. mouth susceptible animals from a foot-and- Art. 23. The movement of foot-and-mouth mouth disease free zone with vaccination, pro- disease susceptible animals involving passage vided the following conditions are met: through regions with different zoosanitary status a) Unvaccinated animals against foot-and- must be defined by MAPA, and the following pro- mouth disease, born or that have remained im- cedures may be followed: mediately after their entry for a minimum of 12 I – Authorization by MAPA after assessment months in a foot-and-mouth disease free zone of the sanitary risks involved; with vaccination, and from rural establishments II – Establishment of the flow of documents registered with the Official Veterinary Service; and information, including the entry request, the b) Animals transported on freight vehicles zoosanitary certificate, and the movement- per with their cargo sealed by the Official Veterinary mit issued by the Official Veterinary Service of Service of the original state; the involved state; c) Animals destined for immediate slaugh- III – Technical procedures may include: sealing ter, which must be sent directly to establishments of the cargo on transport vehicles; definition of the with official veterinary inspection service, while transport route; specification of fixed inspection the procedures referred to under Art. 21 above checkpoints for the entry of animals; and cleaning shall be waived; and and disinfection of the transport vehicles. d) For purposes other than slaughtering, the Art. 24. The state Official Veterinary Services entry may be authorized pursuant to the provi- should maintain at the local veterinary units a sions of Art. 21 hereunder, consistently with the register of animal carriers, whether these are le- following zoosanitary procedures: gal or natural persons. 1. The animals must receive an individual, Sole Paragraph. Depending on the epide- permanent, or long-lasting identification and re- miologic situation, the Official Veterinary Service main isolated for a period of at least 30 days prior may require that vehicles that transport foot-and- to shipment in a location approved by and under 86 mouth susceptible animals be washed and disin- the supervision of the Official Veterinary Service fected after the animals are unloaded or as they of the original state; pass through the fixed inspection checkpoints, as 2. Performance of diagnostic tests for foot- well as prohibiting the use of straw, wood shav- and-mouth disease, as defined by MAPA, on sam- ings, or any other organic matter on the floor of ples collected after at least fourteen days from transport vehicles. the quarantine’s start; 3. Proof of negative results of the diagnostic Section II tests performed; and Entry of animals into foot-and-mouth 4. The animals must remain confined at disease free zone without vaccination destination, under the supervision of the Official Art. 25. The entry of animals vaccinated Veterinary Service for a period of at least 14 days. against foot-and-mouth disease into free zones During the evaluation period, the exit of any without vaccination is prohibited. other foot-and-mouth susceptible animals from Art. 26. The entry of foot-and-mouth sus- the destination establishment shall be forbidden, ceptible animals into free zones without vaccina- save for immediate slaughter. tion shall be authorized for: Paragraph 1. If the diagnostic tests referred I – Animals born or that have remained for at to under Item II, d, 2 above yield at least one pos- least 12 months immediately after their entry in itive result, the entire group of animals shall be barred from entering the free zone without vacci- the Official Veterinary Service of the destination nation, and the following actions shall be carried state, as the case may be. out at the original state, to clarify the positive re- II – Susceptible animals from a buffer zone action to the diagnostic tests done, during which or from a state or part thereof classified as BR-3 time the establishment shall remain interdicted (medium risk) for foot-and-mouth disease or pending the investigation’s final result: into another, similar risk category eventually ad- I – Epidemiologic investigation on the rural opted by MAPA: establishment of origin, taking into consideration a) The animals should proceed directly from the clinical evaluation of susceptible animals; the aforementioned region where they have re- II – Positive sheep and goats shall be sub- mained for at least 12 months prior to the issu- mitted to the collection of samples of the esoph- ance of the authorization, or since their birth, in ageal-pharyngeal liquid for viral research or to the case of animals under 12 months of age; or other diagnostic procedures defined by MAPA; from a livestock establishment where foot-and- III – In case of positive reaction in pigs, sero- mouth disease has not been officially recorded in logic tests must be extended to other animals on the 12 months preceding the date of shipment, the livestock establishment, as defined by the Of- provided no case of foot-and-mouth disease has ficial Veterinary Service, based on epidemiologi- been recorded within a 25-km radius from said cal signs in each case, or other diagnostic proce- establishment in the six months prior to ship- dures defined by MAPA must be followed; and ment. The animals must not show any clinical IV – MAPA should be informed of the epide- signs of the disease on the day of shipment; miologic investigation under way and may deter- b) The animals must be kept in isolation for mine other actions to be carried out in each case. at least 30 days prior to shipment in an officially Paragraph 2. In the case of pigs from GRSC approved location, under Official Veterinary Ser- farms (Certified Pig Reproducer Farm), the diagnos- vice supervision, and must be subjected to the tic tests referred to under this Article are waived. laboratory tests determined by MAPA for foot- and-mouth disease. Diagnostic samples must be Section III collected at least fourteen days after quarantine Entry of animals into foot-and-mouth has started, and must be analyzed at laborato- disease free zone with vaccination ries of the Agriculture and Livestock Health Care Unified System’s Agriculture and Livestock Labo- Art. 27. Permission for the entry of foot-and- 87 mouth susceptible animals into a free zone with ratories Network. At MAPA’s discretion, laboratory vaccination shall be subject to compliance with tests may be waived if the animals are destined the following zoosanitary requirements: for immediate slaughter. I – Animals from foot-and-mouth disease c) If the animals are not destined for slaugh- free zones without vaccination: ter and if laboratory tests identify at least one a) Sheep, goats, pigs, and other susceptible positive animal, the entire group of animals animals, with the exception of cattle and buffalo, must be barred from the foot-and-mouth disease are exempted from additional requirements per- free zone with vaccination. For the purposes of taining to foot-and-mouth disease; slaughter, should laboratory tests be required, b) Cattle and buffalo, with the exception of only animals that test positive will be denied en- those destined for immediate slaughter and other try into the free zone, while the others may be animals MAPA may authorize, must be promptly taken directly to the slaughterhouse; and vaccinated against foot-and-mouth disease in d) At the destination, the animals must be the destination state; and kept in isolation for no less than fourteen days in c) As regards cattle and buffalo that are not an officially approved location and under official destined for slaughter, the Official Veterinary veterinary supervision. Service of the state, of origin must send advance Paragraph 1. Pigs from GRSC farms must notification of the movement of said animals to conform only to the provisions under item II, a and b of this Article; diagnostic tests will not be foot-and-mouth disease or under a similar risk required. category that may be eventually adopted, which Paragraph 2. Should diagnostic tests referred are not recognized as foot-and-mouth disease to in item II above yield at least one positive free zones, should said animals come from states result, an investigation should be done at the that have a lower risk classification, they must establishment of origin, in accordance with the meet the requirements under Art. 27, II hereun- provisions of Art. 26, Paragraph 1 hereunder. der, except for the diagnostic tests requirement. Paragraph 3. Cattle, buffalo, goats, and sheep Art. 29. In case of temporary suspension of up to six months of age, whether or not accom- the recognition as foot-and-mouth disease free panied by their mothers, are exempted from the zones because of the disease’s occurrence, the aforementioned laboratory tests; they should be movement of foot-and-mouth susceptible ani- individually identified and put on the list shown mals and of risk products and subproducts from in the pertinent form. the involved states, or parts thereof, including Paragraph 4. If there are foot-and-mouth sus- protection zones and containment zones, must ceptible animals in the establishment approved be subjected to specific procedures determined for isolation at the destination, said animals can- by MAPA after evaluation of each case. not be moved during the isolation period, unless Art. 30. The movement of pigs involving they are taken directly to slaughter. GRSC farms or a similar classification eventually Paragraph 5. In exceptional cases pertaining adopted by MAPA and not covered hereunder, to slaughter capacity and available means at the irrespective of the foot-and-mouth disease risk origin, MAPA may authorize the entry of pigs des- classification at the origin, may be authorized tined for immediate slaughter irrespective of the by MAPA after evaluation supported by technical foot-and-mouth disease risk classification at the opinion issued by the Official Veterinary Service origin, provided the animals meet the following of the state of origin. zoosanitary requirements: Art. 31. The movement of animals through I – They come from establishments regis- an infected zone, to which the provisions of Art. tered with and supervised by the Official Veteri- 28 above do not apply, should meet the follow- nary Service; ing requirements, irrespective of the purpose II – They have remained at the establish- envisaged: ment of origin since birth; I – The animals must come from a livestock 88 III – They have been quarantined at the establishment where no foot-and-mouth disease origin under official veterinary supervision and outbreak has been detected in the previous 60 subjected to diagnostic tests for foot-and-mouth days, provided no foot-and-mouth disease case disease as determined by MAPA; and has occurred in its proximity within a 25-km ra- IV – They are to be sent directly to slaughter- dius in the previous 30 days; houses under official inspection, except for those II – In the case of cattle and buffalo from re- qualified for international markets that have spe- gions where foot-and-mouth disease vaccination cific requirements as to the animals’ origin. is mandatory, the Official Veterinary Service must provide proof that vaccination has been done Section IV pursuant to the guidelines established under Movement of animals involving buffer Chapter V hereunder; zones, infected zones, and other areas as III – Cattle and buffalo from a foot-and- regards the foot-and-mouth disease risk clas- mouth disease free zone without vaccination sification must be vaccinated upon arrival and revacci- Art. 28. In the case of foot-and-mouth sus- nated after they have been under the control of ceptible animals meant for entry into a buffer the Official Veterinary Service for 30 days, should zone and into states, or into regions classified at foot-and-mouth disease vaccination be manda- least under the BR-3 category (medium risk) for tory at the destination region. CHAPTER VII Art. 35. The entry of the products listed below into a foot-and-mouth disease free zone CONTROL AND INSPECTION OF without vaccination shall be permitted, provided THE MOVEMENT OF PRODUCTS AND their origin and specific zoosanitary procedures SUBPRODUCTS FROM ANIMALS are taken into consideration: SUSCEPTIBLE TO FOOT-AND-MOUTH I – Products from a foot-and-mouth disease DISEASE free zone with vaccination: (a) Boned or unboned fresh meat of cattle Art. 32. To be marketed, any animal prod- or buffalo that have remained in a foot-and- uct or subproduct must be accompanied by a mouth disease free zone with vaccination for sanitary certificate as determined by the Official the preceding 12 months or since birth. The Veterinary Service. meat must be from animals that have not shown Art. 33. Animal products from a foot-and- clinical signs of infectious vesicular disease at mouth disease free zone without vaccination the time of shipment for slaughtering or during and from an establishment forming part of the the ante-mortem examination, and regarding Brazilian Animal Products Inspection System which the post-mortem has not detected any may be freely moved throughout the national lesions suggestive of foot-and-mouth disease, territory. and that have been slaughtered at a slaughter- Art. 34. The entry of the products and sub- house with official veterinary inspection and products listed below from anywhere on the forming part of the Brazilian Animal Products national territory into a foot-and-mouth disease Inspection System; free zone without vaccination shall be permit- b) Boned or unboned fresh meat and fresh ted, without prejudice of other legal instruments viscera of sheep, goats, pigs, and other suscepti- in force: ble animals that have remained since birth or for I – Meat and viscera destined for human the preceding 12 months in a foot-and-mouth consumption, subjected to sufficient thermal disease free zone with vaccination, slaughtered treatment to inactivate the foot-and-mouth dis- at slaughterhouses with official veterinary in- ease virus; spection and forming part of the Brazilian Ani- II – Hides and skins, tanned or in any indus- mal Products Inspection System; trialization stage; c) Fresh milk transported under refrigera- 89 III – Pasteurized milk, or long life milk tion in appropriate sealed tank trucks from es- subjected to ultra high temperature treatment tablishments with official veterinary inspection (UHT); and forming part of the Brazilian Animal Prod- IV – Hooves, horns, hair, and mane sub- ucts Inspection System, for immediate process- jected to treatment capable of inactivating the ing; and foot-and-mouth disease virus, dried and prop- d) Raw hides and skins from slaughterhous- erly packaged; es with official veterinary inspection or that have V – Industrial animal feed; been subjected to treatment in sea salt brine VI – Tallow (melted grease) and meat and containing 2 percent of sodium carbonate for at bone meal; least seven days. VII – Gelatin and hydrolyzed collagen from II – Products from a buffer zone or from a bovine and swine skin; and state, classified at least under the BR-3 category VIII – Other products and byproducts of (medium risk) pertaining to foot-and-mouth dis- foot-and-mouth susceptible animals, subjected ease or under another, similar category eventu- to sufficient treatment to inactivate the viral ally adopted by MAPA: agent, and other products and subproducts not a) Deboned beef: specified hereunder, subject to MAPA’s decision 1. From animals that have remained in a and authorization after specific risk evaluation. specified region of origin for 12 months prior to the issuance of the authorization, or since birth, I – Deboned beef: in the case of animals under one year of age, a) From animals that have remained for which have not shown any signs of infectious ve- at least three months prior to slaughter in the sicular disease at the time of being shipped for specified region of origin, where no occurrence slaughter; of foot-and-mouth disease has been recorded in 2. From slaughterhouses with official veteri- the preceding 60 days, provided also that no case nary inspection and forming part of the Brazil- of foot-and-mouth disease has occurred in the ian Animal Products Inspection System; and preceding 30 days within a 25-km radius around 3. Subjected before deboning to a sanitary the establishment. In addition, the animals have ageing temperature over 2º C for at least 24 not shown any sign of infectious vesicular dis- hours after slaughtering, provided the pH con- ease at the time of being shipped for slaughter; tent does not exceed 6 at the center of the long- b) From slaughterhouses with official veteri- issimus dorsi muscle; nary inspection and forming part of the Brazil- b) Fresh meat of goat, sheep, pigs, and other ian Animal Products Inspection System; and susceptible animals from slaughterhouses with c) Subjected, prior to deboning, to sanitary official veterinary inspection and forming part ageing at a temperature above 2º C for at least of the Brazilian Animal Products Inspection 24 hours after slaughtering, provided the pH System and destined for another establishment content does not exceed 6 at the center of the with official veterinary inspection and forming longissimus dorsi muscle. part of the Brazilian Animal Products Inspection II – Fresh meat of goat, sheep, pigs, and System, where it will be subjected to treatment other susceptible animals that meet the same sufficient for inactivating the foot-and-mouth requirements as for fresh beef, except for the disease virus; deboning and ageing requirement; c) Fresh milk transported under refrigera- III – Fresh viscera from a slaughterhouse tion in appropriated sealed tank trucks from an with official veterinary inspection and forming establishment with official veterinary inspec- part of the Brazilian Animal Products Inspection tion and forming part of the Brazilian Animal System, destined for processing for optothera- Products Inspection System and destined for peutic purposes or for the production of animal industries with official veterinary inspection and feed at MAPA-approved establishments; forming part of the Brazilian Animal Products In- IV – Fresh milk transported under refrigera- 90 spection System, for immediate processing; tion in appropriated sealed tank trucks from an d) Raw hides and skins subjected to treat- establishment with official veterinary inspec- ment in sea salt brine with a 2 percent sodium tion and forming part of the Brazilian Animal carbonate content for at least 28 days; Products Inspection System and destined for Sole Paragraph. Products must be trans- industries with official veterinary inspection and ported in vehicles with the cargo sealed by the forming part of the Brazilian Animal Products Official Veterinary Service of the state of origin Inspection System; and or subjected to another type of control autho- V – Raw hides and skins subjected before rized by the Official Veterinary Service, and must shipment to treatment in sea salt brine with 2 enter the foot-and-mouth disease free zone percent of sodium carbonate for at least 14 days. through entry points previously established and Sole Paragraph. Products must be trans- approved by MAPA. ported in vehicles with the cargo sealed by the Art. 36. The entry of the products listed below Official Veterinary Service of the state of origin into a foot-and-mouth disease free zone with vac- or subjected to another type of control autho- cination from a buffer zone or from a state or parts rized by the Official Veterinary Service, and must thereof, classified at least under the BR-3 category enter the foot-and-mouth disease free zone (medium risk) for foot-and-mouth disease or under through entry points previously established and another, similar category eventually adopted: approved by MAPA. Art. 37. The entry of raw skins and hides into a CHAPTER VIII foot-and-mouth disease free zone with vaccination shall be permitted if they come from states classi- INTERNATIONAL MOVEMENT OF FOOT- fied as being of high or unknown risk for foot-and- AND-MOUTH SUSCEPTIBLE ANIMALS AND mouth disease or under another similar category PRODUCTS AND SUBPRODUCTS THEREOF eventually adopted, provided they are subjected to treatment in sea salt brine with a 2-percent sodium Art. 42. The importation of foot-and-mouth carbonate content for at least 28 days. susceptible animals and of products and sub- Art. 38. The entry of semen, embryos, or products thereof shall be prohibited if they come ovocytes of foot-and-mouth disease susceptible from countries, regions, or zones not on OIE’s List animals into a foot-and-mouth disease free zone of Foot-and-Mouth Disease Free Countries, save shall be permitted, provided they have been ob- for the exceptions hereunder. tained and processed pursuant to international Art. 43. The importation of fresh deboned technical norms at a center registered with the meat from bovine carcasses shall be permit- Official Veterinary Service located in a state, clas- ted if: sified at least as being of medium risk for foot- I –It has been taken from animals that have and-mouth disease or under another, similar remained in the exporting country for two years category eventually adopted by MAPA, provided prior to slaughter or since birth in areas where they meet the requirements specified under Art. official control measures have been introduced 27, II, a and b hereunder and are accompanied and are in force; by a zoosanitary certificate. II – It has been taken from animals from Art. 39. The entry of meat and meat prod- an establishment where no foot-and-mouth ucts and fresh viscera into a foot-and-mouth disease outbreak has occurred in the 60 pre- disease free zone with or without vaccination ceding days, provided also that no foot-and- shall be permitted, provided they are properly mouth disease case has been detected in the packaged and conditioned and are destined surrounding area, within a 25-km radius, in the for exportation through ports, airports, border 30 preceding days; posts, and other warehouse premises at these III - It has been taken from animals slaugh- locations, from any state, as long as they come tered in slaughterhouses qualified for exporting from establishments licensed by MAPA for expor- to Brazil; 91 tation, and are accompanied by the pertinent IV – It has been taken from carcasses from sanitary documentation. which the main lymph nodes have been re- Sole Paragraph. The transport vehicle must moved; and be sealed at the origin and the seal may be bro- V – It has, before deboning, been subjected ken only at the destination by the Official Veteri- to sanitary ageing at a temperature above 2º C for nary Service. at least 24 hours after slaughtering, and the pH Art. 40. The entry of pathogenic material at the center of the longissimus dorsi muscle in for any purpose into a foot-and-mouth disease each half of the carcass does not exceed 6. free zone with or without vaccination is prohib- Art. 44. The importation of products con- ited, unless it has been previously authorized by taining beef as raw material shall be permitted, MAPA. provided the provisions under Art. 43 hereunder Art. 41. The entry, into a foot-and-mouth are observed. disease free zone with or without vaccination, Art. 45. The importation of products con- of products and subproducts of foot-and-mouth taining beef, offal, and viscera as raw material susceptible animals, which have not been speci- shall be permitted, as long as they have been fied hereunder, including material of scientific subjected to procedures for inactivation of the interest and for industrial use shall require prior foot-and-mouth disease virus, pursuant to OIE MAPA authorization. recommendations. Art. 46. The importation of bovine semen I – Water steam in an environment closed for and embryos shall be permitted, provided the at least 10 minutes at a temperature of at least provisions under Art. 43, I-II hereunder are com- 80º C; or plied with and the following conditions are met: II –Phormol steam (phormaldehyde gas) I – They have been collected at artificial in- produced from a 35-40 percent solution in an semination centers or other establishments regis- environment closed for at least 8 hours at a tem- tered with or approved by the Official Veterinary perature of at least 19º C. Service of the exporting country and meet both Art. 48. The importation of other animal the general and the specific conditions recom- products shall be permitted, provided they mended by OIE; are subjected to the OIE-recommended proce- II – They have been collected, processed, and dures for inactivation of the foot-and-mouth stored pursuant to OIE guidelines, in the case of disease virus, semen, and to the International Embryo Transfer Art. 49. The zoosanitary certificates ac- Society’s guidelines, in the case of embryos; and companying the goods referred to hereunder III – The exporting country’s Official Veteri- must contain the specific guarantees defined nary Service certifies compliance with the Brazil- for each case. ian zoosanitary requirements applicable to the Art. 50. The importation conditions hereun- goods in question. der shall apply without prejudice of other sani- Art. 47. The importation of straw and fodder tary requirements in force. from countries, regions, or zones on OIE’s List of Foot-and-Mouth Disease Free Countries, or from CHAPTER IX establishments where in the 30 days preceding collection no foot-and-mouth disease outbreak FINAL DISPOSITIONS has occurred and in whose surroundings within a 3-km radius no outbreak has been detected ei- Art. 51. Omissive cases and doubts pertain- ther, provided such products have been subjected ing to this Act’s execution shall be resolved by to one of the following treatments: MAPA.

92 ANNEX II (Model) APPLICATION FOR THE ENTRY OF FOOT-AND-MOUTH DISEASE SUSCEPTIBLE ANIMALS INTO A FOOT-AND-MOUTH DISEASE FREE ZONE, BUFFER ZONE, OR MEDIUM RISK ZONE

( ) WITHOUT VACCINATION ( ) WITH VACCINATION ( ) BUFFER ZONE OR MEDIUM RISK ZONE

As we are interested in bringing foot-and-mouth susceptible animals into the region indicated above, we hereby request authorization in accordance with the provisions of the Ministry of Agriculture, Livestock, and Food Supply’s ______No. ______/07, and to that end we submit the following information: 1. Information about the animals’ origin and characterization Origin:

State Municipality:

Establishment’s name:

Name of the person responsible for the animals at the origin:

Address for contact

Phone: FAX E-mail Information about the animals: Species: Purpose: Quantity:

Additional information on the animals (if necessary)

93 2. Information about the destination

State Municipality:

Establishment’s name:

Name of the Person responsible for the animals at the destination:

Phone: FAX E-mail

Means of transportation Land Air Sea Other:

Point of entry:

______Place and date ______Applicant’s name and signature ANNEX III (Model) AUTHORIZATION FOR THE ENTRY OF FOOT-AND-MOUTH DISEASE SUSCEPTIBLE ANIMALS INTO A FOOT-AND-MOUTH DISEASE FREE ZONE, BUFFER ZONE, OR MEDIUM RISK ZONE

( ) WITHOUT VACCINATION ( ) WITH VACCINATION ( ) BUFFER ZONE OR MEDIUM RISK ZONE No. ______/ ______

I HEREBY AUTHORIZE the entry of the animals identified bellow in accordance with the provisions of the Ministry of Agriculture, Livestock, and Food Supply’s ______No. ______/07, subject to compliance with the following: I. The animals must be moved to the destination establishment identified hereunder, under the supervision of the designated Official Veterinary Service for the purposes of: ( ) confinement, observation for at least ____ days; ( ) performance of the requisite laboratory tests; II. This authorization shall be valid solely for entry at the specified entry point specified hereunder; III. This authorization may be cancelled at any time if any change occurs in the sanitary status of the livestock establishment of origin or of the state of origin, at the discretion of the Animal and Plant Health and Inspection Secretariat’s Animal Health Department.

Information about the destination’s confinement site: State Municipality:

Establishment’s name:

Name of the Person responsible for the animals at the destination:

Phone: FAX E-mail:

Means of transportation: Land Air Sea Other: 94 Point of entry:

Information about the animals: Species: Purpose: Quantity:

Additional information about the animals (please attach a list with individual identification)

Origin: State Municipality:

Establishment’s name:

Name of person responsible for the animals at the origin:

Place and date of issuance

Seal and signature of authorizer

1st copy: Receiver 2nd copy: State of origin 3rd copy: Point of entry 4th copy: Authorizer ANNEX IV (Model) ZOOSANITARY CERTIFICATE OF ORIGIN FOR THE ENTRY OF FOOT-AND-MOUTH SUSCEPTIBLE ANIMALS INTO A BUFFER ZONE OR MEDIUM RISK ZONE

( ) WITHOUT VACCINATION ( ) WITH VACCINATION ( ) BUFFER ZONE OR MEDIUM RISK ZONE

ADDITION TO THE ANIMAL MOVEMENT PERMIT (GTA) No. ____/______

SPECIES INVOLVED: Bovine Bubaline Goat Sheep Pig Other ______

I hereby certify, for the purposes of entry into a foot-and-mouth disease free zone, a buffer zone or medium risk zone, pursuant to Ministry of Agriculture, Livestock, and Food Supply’s Normative Instruction No. ______/07, that the animals identified below meet the following conditions: ( ) 1. They have been born and reared on the establishment of origin, where they have spent the last ______months prior to shipment. ( ) 2. They meet the conditions stipulated under Arts. ______of Ministry of Agriculture, Livestock, and Food Supply’s Normative Instruction No. _____/07. ( ) 3. In the state of origin where the establishment of origin is located, the vaccination of cattle and buffalo is regularly practiced and officially controlled. ( ) 4. In the state the Official Veterinary Service is structurally organized and meets the requisite legal provisions for inspecting the movement of animals, exercising epidemiologic and sanitary surveillance, and imposing the interdiction of the disease’s outbreaks, as well as enforcing other animal health and Inspection measures. ( ) 5. They have been kept in confinement for 30 days prior to shipment, in an officially approved environment and under official veterinary supervision, and have not shown any clinical sign of transmissible disease when subjected to the officially approved foot-and-mouth disease tests. ( ) 6. The pigs have been born and reared at an establishment officially certified as CERTIFIED PIG REPRODUCERS FARM pursuant to the zoosanitary norms in force. ( ) 7. Animals’ identification:

No. Identification Breed Gender Age No. Identification Breed Gender Age (months) (months) 1 11 95 2 12 3 13 4 14 5 15 6 16 7 17 8 18 9 19 10 20

Continuation in attached sheet? ( ) Yes ( ) No Obs.:

Identification and signature of the veterinary doctor at the state Official Veterinary Service

Seal Signature COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING No. 17 OF JANUARY 12, 2007

Published in the Official Gazette No. 12, Section 2, page 4, Wednesday, January 17, 2007

Establishes the Biosecurity Commission on the Foot-and-mouth Disease Virus under the Animal and Plant Health and Inspection Secretariat - SDA.

ADMINISTRATIVE RULING No. 43 OF FEBRUARY 10, 2006

Published in the Official Gazette of February 13, 2006, Section 1, Page 2

Declares the State of Paraná’s Center-South region, which consists of the municipalities and parts of the municipalities listed in the Annex, as free of foot-and-mouth disease with vaccination.

ADMINISTRATIVE RULING No. 9 OF JANUARY 15, 2004

Published in the Official Gazette of January 19, 2004, Section 1, Page 12

Declares the State of Acre, the Municipalities of Guajará and Boca do Acre in the State of Amazonas, and the Municipalities located in the Center-South region of the State of Pará free of foot-and-mouth disease with vaccination.

ADMINISTRATIVE RULING No. 543 OF OCTOBER 22, 2002

96 Published in the Official Gazette of October 23, 2002, Section 1, Page 3

Declares the State of Rondônia free of foot-and-mouth disease with vaccination.

ADMINISTRATIVE RULING No. 582-A OF DECEMBER 28, 2000

Published in the Official Gazette of January 12, 2001, Section 1, Page 52

Establishes a Buffer Zone in the States of Tocantins and Bahia, consisting of the municipalities listed under Annex I, to separate the foot-and-mouth disease free zone with vaccination from the other States considered as infected.

ADMINISTRATIVE RULING No. 153 OF APRIL 27, 2000

Published in the Official Gazette of April 28, 2000, Section 1, Page 78

Declares the zone consisting of the States of Rio Grande do Sul and Santa Catarina as a foot-and-mouth disease free zone without vaccination. ADMINISTRATIVE RULING No. 713 OF NOVEMBER 12, 1995

Published in the Official Gazette of November 7, 1995, Section 1, Page 17760

Approves Norms for the Production, Control, and Use of Vaccines against Foot-and-Mouth Disease, and revokes Administrative Ruling No. 533 of October 22, 1993

ADMINISTRATIVE RULING No. 194 OF NOVEMBER 29, 1994

Published in the Official Gazette of December 09, 1994, Section 1, Page 8968

Establishes the Coordination Commission of Livestock Circuits, as listed hereunder, to harmonize and coordinate the actions of public and private agencies involved in foot-and- mouth disease control and eradication.

ADMINISTRATIVE RULING No. 177 OF OCTOBER 27, 1994

Published in the Official Gazette of November 10, 1994, Section 1, Page 16875

Biologic Security Norms on the Manipulation of the Foot-and-Mouth Disease Virus.

ADMINISTRATIVE RULING No. 768 OF DECEMBER 13, 1993

Published in the Official Gazette of December 15, 1993, Section 1, Page 19371

Order the Animal and Plant Health and Inspection Secretariat, through the Animal Health and Inspection Department, to undertake the monthly publication of lab results in the media by the 10th day of the month following the performance of the qualitative tests of 97 foot-and-mouth disease vaccines.

ADMINISTRATIVE RULING No. 16 OF JANUARY 26, 1989

Published in the Official Gazette of January 30, 1989, Section 1, Page 1641

Prohibits on the entire National Territory the researching, production, marketing, and use of foot-and-mouth disease vaccine made from modified live virus.

NORMATIVE INSTRUCTION No. 25 OF JUNE 28, 2007

Published in the Official Gazette of July 2, 2007, Section 1, Page 2

Includes the State of Para’s center-south region consisting of the listed municipalities and parts of municipalities in the internationally recognized foot-and-mouth disease free zone with vaccination. NORMATIVE INSTRUCTION No. 61 OF NOVEMBER 6, 2006

Published in the Official Gazette No. 214 of November 8, 2006, Section 1, Page 67

Lifts the restrictions imposed under SDA Normative Instruction No. 9 of March 15, 2006.

NORMATIVE INSTRUCTION No. 51 OF SEPTEMBER 21, 2006

Published in the Official Gazette of September 25, 2006, Section 1, Page 2

Lifts the restrictions imposed under SDA Normative Instruction No. 9 of March 15, 2006 on the areas under sanitary risk related to outbreaks detected in the Municipalities of Bela Vista do Paraíso, Grandes Rios, Maringá, and São Sebastião da Amoreira, identified in Art. 1, II of the aforementioned Normative Instruction.

NORMATIVE INSTRUCTION No. 14 OF JULY 6, 2005

Published in the Official Gazette No. 129 of Thursday, July 7, 2005, Section 1, Page 2

Includes the State of Acre and the Municipalities of Boca do Acre and Guajará, State of Amazonas, in the zone free of foot-and-mouth disease with vaccination, consisting of the States of Bahia, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio de Janeiro, Rio Grande do Sul, Santa Catarina, São Paulo, Sergipe, Tocantins, and the Federal District.

98 NORMATIVE INSTRUCTION SDA No. 61 OF AUGUST 18, 2003

Published in the Official Gazette No. 164 of Tuesday, August 26, 2003, Section 1, Pages 6-8 as amended by Normative Instruction No. 25 of June 28, 2007.

Establishes the procedures hereunder as a condition for the entry of animals susceptible to foot-and-mouth disease, as well as their products and subproducts into the State of Pará in connection with the interstate movement of animals, without prejudice of other sanitary norms in force.

NORMATIVE INSTRUCTION No. 7 OF JUNE 11, 2003

Published in the Official Gazette No. 112 of Thursday, June 12, 2003, Section 1

Includes the State of Rondônia in the zone free of foot-and-mouth disease with vaccination, consisting of the States of Bahia, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio de Janeiro, Rio Grande do Sul, Santa Catarina, São Paulo, Sergipe, Tocantins, and the Federal District. NORMATIVE INSTRUCTION No. 11 OF MAY 9, 2001

Published in the Official Gazette No. 90 of Thursday, May 10, 2001, Section 1

Orders the immediate vaccination of all the bovine and bubaline herds in the State of Rio Grande do Sul.

NORMATIVE INSTRUCTION No. 6 OF JULY 13, 2000

Published in the Official Gazette of July 14, 2000, Section 1, Page 95

Establishes a Buffer Zone in the States of Bahia and Tocantins, separating the possible foot-and-mouth disease free zone with vaccination from the other States considered as infected.

NORMATIVE INSTRUCTION No. 229 OF DECEMBER 7, 1998

Published in the Official Gazette No. 1 of Monday, January 4, 1999, Section 1

Authorizes the use of a Guarantee Seal on foot-and-mouth disease vaccine ampoules, and makes other provisions.

NATIONAL PROGRAM FOR THE CONTROL AND ERADICATION OF ANIMAL 99 BRUCELLOSIS AND TUBERCULOSIS

ADMINISTRATIVE RULING No. 11 OF JANUARY 26, 2004

Published in the Official Gazette of January 29, 2004, Section 1, Page 3

Exempts the State of Santa Catarina from the compulsory vaccination of cattle and buffalo females against brucellosis

THE DIRECTOR OF THE ANIMAL HEALTH AND IN- proved by Ministerial Administrative Ruling no.574 SPECTION DEPARTMENT OF THE MINISTRY OF AGRI- of December 8, 1998, and under Art. 13 of SDA Nor- CULTURE, LIVESTOCK, AND FOOD SUPPLY’S Animal mative Instruction No. 6 of January 8, 2004, and Plant Health and Inspection Secretariat, WHEREAS the soroepidemiologic investiga- by virtue of the powers vested in him under Art. tion of bovine brucellosis undertaken by the 84, VIII of the Secretariat’s Internal Regulations ap- State of Santa Catarina’s sanitary authorities has detected low prevalence of properties and ani- RESOLVES: mals infected with the disease; Art. 1. To exempt the State of Santa Catarina WHEREAS, given the low prevalence de- from the compulsory vaccination of cattle and tected, vaccination will not yield beneficial ef- buffalo females against brucellosis. fects, and in view of the possibility that the use of Art. 2. The actions to be carried out in areas vaccine prepared with B19 sample may interfere in the process of eradicating the disease shall be with the results of diagnostic tests, a procedure defined under a specific act issued by the Animal systematically used in areas in the process of Health and Inspection Department-DDA. eradicating the disease, and in light of Proceed- Art. 3. This Administrative Ruling shall enter ing No. 21000.013020/2003-71, into force on the date of its publication.

JOÃO CRISOSTOMO MAUD CAVALLÉRO

NORMATIVE INSTRUCTION SDA No. 33 OF AUGUST 24, 2007

Published in the Official Gazette of August 28, 2007, Section 1, Page 6

Establishes the conditions for the vaccination of cattle females against brucellosis with a RB51 sample vaccine.

THE MINISTRY OF AGRICULTURE, LIVESTOCK against brucellosis on male cattle of any age, on HEALTH AND FOOD SUPPLY’S AGRICULTURE AND females aged up to eight months, and on preg- LIVESTOCK AND INSPECTION SECRETARY, by virtue nant females is hereby prohibited. of the powers vested in him under Arts. 9 and 42, Art. 5. The marketing of the RB51 sample Annex I of Decree No. 5351 of January 21, 2005, vaccine against brucellosis may be done solely having in view the provisions under Decree No. by duly registered and authorized commercial 24548 of July 3, 1934; SDA Normative Instruction establishments and shall be subject to the official No. 6, of January 8, 2004; and Proceeding No. service’s inspection. 21000.004860/2005-13, Paragraph 1. Acquisition of the vaccine shall 100 RESOLVES: be permitted solely against a pertinent prescrip- Art. 1. To set forth the conditions for the vac- tion, pursuant to the form shown in Annex I cination of cattle females against brucellosis with hereto, issued by a veterinary doctor registered a RB51 sample vaccine. with the official and Inspection service of the per- Art. 2. The vaccination of female cattle with tinent state. a RB51 sample vaccine shall be recommended in Paragraph 2. The veterinary doctor’s pre- the following cases: scription shall be kept by the commercial estab- I – Females aged over eight months that lishment and shall include the veterinary doctor’s have not been vaccinated with B19 sample be- full name and signature, his registration number tween three and eight months of age; or with the Veterinary Medicine Council (CRMV), his II – Adult females that do not react to diag- registration number with the official and Inspec- nostic tests on rearing establishments with bru- tion service, as the case may be, the number of cellosis outbreak. doses to be purchased, and the place and date. Art. 3. The vaccination referred to in the Art. 6. The commercial establishment shall preceding Art. shall be performed under the re- apprise the official service of the purchase, sale, sponsibility of a veterinary doctor registered with and stock of the RB51 sample vaccine, as pre- the Official Veterinary Service of the state as the scribed under Annex II hereto. case may be. Art. 7. The veterinary doctor responsible Art. 4. The use of a RB51 sample vaccine for the vaccination shall issue a vaccination certificate in three copies, of which the first shall scribed under Annex III or Annex IV hereunder, be kept by the owner, the second by the local as the case may be. unit of the official service of the state as the Art. 8. This Normative Instruction shall enter case may be, and the third by the issuer, as pre- into force on the date of its publication.

INÁCIO AFONSO KROETZ

ANNEX I

PRESCRIPTION FOR THE PURCHASE OF RB51 SAMPLE VACCINES

Veterinary doctor’s name:

No. of registration with the state’s official service:

No. of registration with the Veterinary Medicine Council (CRMV):

Address:

Phone:

Vaccine: RB51 sample

Quantity of doses ______( ______). 101

Place and date

Veterinary doctor’s signature and seal ANNEX II

REPORT ON THE MARKETING OF RB51 SAMPLE VACCINE AGAINST BRUCELLOSIS

Commercial establishment: Address and telephone: Municipality: State: Period covered:

PURCHASE: Date Laboratory Lot No. vials No. doses Expiration

SALE: Veterinarian’s name and Laboratory Lot No. vials No. Expiration registration nº. doses

102

CURRENT STOCK: Date Laboratory Lot No. vials No. doses Expiration

OBSERVATIONS: Place and date: Name and signature of the person in charge: ANNEX III

CERTIFICATE OF VACCINATION AGAINST BRUCELLOSIS RB51 SAMPLE VACCINE

I hereby certify that ______(______) females were vaccinated against brucellosis on ______’s property known as ______, registered with the official state service under No.______and located in the Municipality of

______, in the state of ______.

The vaccine used was the RB51 sample vaccine produced by the ______laboratory, lot No. ______, manufactured on ______, and valid until ______.

Place and date of vaccination

103

Veterinary Doctor

CRMV Registration No.______and No. of registration

with the state official health and inspection service ______ANNEX IV

CERTIFICATE OF VACCINATION AGAINST BRUCELLOSIS RB51 SAMPLE VACCINE

(Form to be used in connection with the vaccination of individually identified females under an appropriate system prescribed by MAPA)

OWNER: PROPERTY’S NAME: No. OF REGISTRATION WITH THE OFFICIAL AND INSPECTION SERVICE: MUNICIPALITY: STATE.: I hereby certify for the pertinent purposes that the females listed below have been vaccinated against brucellosis with the RB51 sample vaccine, lot nº. manufactured by the laboratory on and with expiration date .

(Females listed by number, name, age, and breed)

1. 2. 3. 4. 5. 6. 104 7.

Place and date of vaccination

Veterinary Doctor CRMV Registration nº. ______and nº. of registration with the state official and Inspection service ______NORMATIVE INSTRUCTION No. 41 OF NOVEMBER 24, 2006

Published in the Official Gazette of November 28, 2006, Section 1, Page 86

Approves “Specific Criteria for Accreditation and Monitoring of Bovine and Bubaline Brucellosis Diagnostic Laboratories.”

THE MINISTER OF AGRICULTURE, LIVESTOCK creditation and Monitoring of Bovine and Buba- AND FOOD SUPPLY, by virtue of the powers vested line Brucellosis Diagnostic Laboratories” pursu- in him under Art. 2 of Decree No. 5741 of March ant to Annexes I-X hereto. 30, 2006 and Proceeding 21000.004434/2006-52, Art. 2. This Normative Instruction shall enter Resolves: into force on the date of its publication. Art. 1. To approve “Specific Criteria for Ac-

LUÍS CARLOS GUEDES PINTO

ANNEX I

SPECIFIC CRITERIA FOR THE ACCREDITATION AND MONITORING OF BOVINE AND BUBALINE BRUCELLOSIS DIAGNOSTIC LABORATORIES

The accreditation and monitoring of bovine they have a veterinary doctor responsible for the and bubaline brucellosis diagnostic laboratories technical area as well as a quality control system. shall be based on this Normative Instruction as 3. DEFINITIONS well as on SDA Normative Instruction No. 51 of 3.1. For the purposes hereunder, the follow June 27, 2003; SDA Normative Instruction No. 6 definitions shall apply: of January 8, 2004; and any acts that may eventu- 3.1.1. Official Health and Inspection Service: 105 ally replace them. service under the Central and Superior Organ and 1. OBJECTIVES: the Intermediate and Local Organs charged with 1.1. To standardize the procedures adopted the promotion of animal health and the preven- by bovine and bubaline brucellosis diagnostic tion, control, and eradication of diseases that laboratories; and may harm animal productivity, the economy, and 1.2. To accredit laboratories provided with a agriculture and livestock health. quality guarantee system, in support of animal 3.1.2. Official veterinary doctor: government health and Inspection actions determined by Health and Inspection service veterinary doctor. the Ministry of Agriculture, Livestock, and Food 3.13. Accredited veterinary doctor: a private Supply-MAPA. sector professional qualified before one of the 2. APPLICATION Agriculture and Livestock Health Care Unified 2.1. This Normative Instruction applies to System’s three Organs to carry out specific animal public and private laboratories interested in join- health and Inspection actions as determined by ing the Agriculture and Livestock Health Care Uni- the Ministry of Agriculture, Livestock, and Food fied System’s National Network of Agriculture and Supply as Central and Superior Organ. Livestock Laboratories in connection with bovine 3.1.4. Owner: any legal or natural person that and bubaline brucellosis diagnostic, provided owns one or more than one cattle and buffalo. 3.1.5. Herd: a group of animals reared under 5. SAMPLES the same management conditions at the same 5.1. Samples to be tested: rearing establishment. 5.1.1.1. Blood serum – a minimum of 2 ml, 3.1.6. Brucellosis: zoonosis caused by Bru- frozen or cooled to a temperature no higher than cella spp, which causes infertility and miscarriage +8º C (eight centigrade degrees); and in late pregnancy, and affects mainly the bovine 5.1.1.2. Milk cooled to a temperature be- and bubaline species. tween +2º C and +8º C (two and eight degrees 3.1.7. Accredited laboratory: a public or centigrade). private laboratory that has been subjected to 6. RECEIVING Agriculture and Livestock Health Care Unified 6.1. Samples must be properly identified, System’s accreditation process and been offi- maintained at a temperature of up to +8º C cially recognized as competent for performing (eight degrees centigrade), and accompanied by official analysis in accordance with the ac- a sample forwarding form (Annex V), filled-out creditation’s scope and the laboratory’s qual- and signed by the accredited veterinary doctor, ity system. with his professional identification, or by the of- 3.1.8. Senior professional: a veterinary doc- ficial animal health and Inspection service; and tor in charge of an accredited laboratory that has 6.1.1. In case the requesting veterinary doc- been subjected to evaluation and approved by tor himself is not the carrier of the collected ma- the competent authority of one of the Agricul- terial, he should designate a proxy pursuant to ture and Livestock Health Care Unified System’s the form shown in Annex VI. Organs and who has responsibility for the labora- 6.2. Serums showing excessive hemolysis, tory’s technical activities. impurities, or signs of bacterial contamination 3.1.9. Reference laboratory: an official labo- should be discarded. ratory of the National Network of Agriculture and 6.3. Samples should be properly recorded in Livestock Laboratories designated by MAPA as a an official log established pursuant to the form reference laboratory for the diagnostic of brucel- shown in Annex IX. losis in light of the Program’s scope. 6.4. Blood received must be centrifuged and 3.1.10. Retesting: a test performed on a the resulting serum must be subjected to the new sample collected from the same animal(s) treatment referred to under the preceding items. under the conditions established under the 6.5. Samples to be tested must be kept un- 106 PNCEBT. der refrigeration until the analysis is performed, 3.1.11. Monitoring: procedures adopted by or frozen if the analysis is done 48 (forty-eight) the accreditation organ to ascertain that the ac- hours after samples are received. credited laboratory continues to be in compli- 7. METHOD ance with the accreditation requirements. 7.1. The tests indicated for the diagnostic of 4. MATERIAL bovine and bubaline brucellosis are as follows: 4.1. Antigen: 7.1.1. Buffered Brucella antigen test (BBAT ), 4.1.1. Only antigens (Ag) registered with MA- as described in Annex II; PA’s competent organ and whose lots have been 7.1.2. 2-Mercaptoethanol (2-ME), as de- tested and approved may be used, provided their scribed in Annex III; validity limits is respected. 7.1.3. Milk ring test, as described in Annex 4.1.2. Antigens must be transported and IV; and maintained at a temperature between +2º C (two 7.2. Modification or addition of any ana- centigrade degrees) and +8º C (eight centigrade lytical method must be previously approved by degrees) and protected from direct sunlight. MAPA’s competent organ. 4.1.3. Accredited laboratories must acquire 8. LABORATORY their antigens from the official health and inspec- 8.1. The laboratory must have the appropri- tion service of their respective state. ate premises, equipment, and operating flow for the performance of brucellosis diagnostic tests, - pH meter; and one or more than one technical professional - hot air oven or water bath at 37º C (thirty- duly approved by MAPA. seven degrees centigrade); 9. FACILITIES - gas exhaustion cabinet; 9.1. All laboratory facilities must be located - minute timer or alarm clock; on the same site. - plain or five-point stirrers; and 9.1.1. Office: an area reserved for receiving - tube racks. and entering samples into the records, issuing re- 10.1.3. Washing and sterilization: sults, and file-keeping. - autoclave; 9.1.2. Analysis room: area reserved for sam- - cuvette with disinfectant solution; and ple processing. Must be provided with sufficient - water distiller or deionizer. and appropriate power outlets and water supply 10.1.4. Reactants: and drainage points for tests; waterproof coun- - specific antigens for each test; ter, walls, and floor for easy washing and disinfec- - control serum and milk, both positive and tion; and air conditioning. negative; 9.1.3. Washing and sterilization: area re- - 0.85 percent saline-0.5 percent phenicate served for washing the materials used in diag- solution; nostic tests and for autoclaving samples and - 0.85 percent saline solution; their discardable residues. Must be provided with - 2-mercaptoethanol; and sufficient and appropriate power outlets and wa- - distilled water. ter supply and drainage points, tanks, or sinks. 11. BIOSAFETY Counters, walls, and floors must be waterproof 11.1. The laboratory must follow the recom- and resistant to washing and disinfection. mended biosafety norms and procedures pertain- 10. EQUIPMENT AND MATERIALS ing to the performance of brucellosis serologic 10.1. A laboratory must have the following diagnostic tests. equipment and materials, as a minimum: 11.2. Before being discarded, samples and 10.1.1. Office: residues must be autoclaved at +121º C (hundred - file with lock; and twenty-one degrees centigrade) for at least 30 - typewriter or personal computer. (thirty) minutes under one-pound pressure. 10.1.2. Analysis room: 11.3. Environmental, Sanitary, and Labor 107 - plate shaker (optional); Security Norms must also be followed in connec- - cuvette with disinfectant solution; tion with lab operations. - light box with indirect lighting for reading 12. RETEST results; 12.1. Samples destined for retest must be - pipetting device, preferentially automatic, accompanied by a request signed by an official or provided with a rubber bulb; or accredited veterinary doctor pursuant to the - grid-patterned glass plates, with 4 cm x 4 form shown in Annex VII; cm squares; 12.2. In retesting, only the 2-ME test shall be - micropipette for volumes ranging from 10 performed. μL to 100 μL; 13. RESULTS AND REPORTS - pointers for volumes ranging from 10 μL 13.1. Results should be issued in three cop- to 100 μL; ies: the first to be kept by the accredited veteri- - laboratory glass vessels; nary doctor that has requested the exam; the sec- - refrigerator and freezer to – 20º C (minus ond to be forwarded to the state animal health twenty degrees centigrade) or two-door refrig- and Inspection department; and the third to be erator; kept in the laboratory file. - centrifuge with a minimum capacity of 13.2. Results should be issued on the perti- 1500 RPM (rotations per minute); nent forms pursuant to the form shown in Annex X and in accordance with the established flow; 13.5. Only the Senior Professional in 13.2.1. POSITIVE or INCONCLUSIVE results: charge may sign the results form and the must be immediately and compulsorily reported to monthly reports. the SFA Agriculture and Livestock Sanitary Health 14. SENIOR PROFESSIONAL IN CHARGE and Inspection Service (SEDESA) and to the accred- 14.1. For the purposes of a laboratory’s ac- ited veterinary doctor that has requested the test. creditation, its senior professional in charge shall 13.2.2. NEGATIVE result: must be reported to be subjected to a capacity evaluation at an of- the veterinary doctor that has requested the test. ficial laboratory or through the remote follow-up 13.3. Reports on operating activities shall of an assay at the laboratory in question, by au- be issued in three copies – the first to be sent ditors designated by the competent authority of to MAPA’s laboratory unit in charge of accrediting one of the Agriculture and Livestock Health Care brucellosis laboratories; the second to be sent to Unified System’s Organs. The decision should be the official and Inspection service that has pro- sent to the laboratory that has provided the ma- vided the antigen; and the third to be kept in the terial, within five business days after receipt of laboratory’s file. the test, in a sealed envelope with a POSTAL RE- 13.4. Reports should be issued on a monthly TURN RECEIPT SLIP (AR). basis according to the model form in Annex VIII 14.2. For monitoring purposes, distance ex- and to the prescribed schedule, as follows: ams may be done and the result may be sent to 13.4.1. To be sent by the fifth of the subse- the laboratory that has provided the material, quent month to MAPA’s laboratory unit in charge within five business days after the test’s receipt, of accrediting brucellosis laboratories and to the in a sealed envelope with a POSTAL RETURN RE- local official health and inspection service from CEIPT SLIP (AR). which the antigens were acquired. 14.3. The Senior Professional may have only 13.4.2. By the 10th of the subsequent month one laboratory unit under his charge. in states where antigens are distributed by the 15. GENERAL DISPOSITIONS state animal health service, which shall forward 15.1. Omissive cases hereunder shall be the report to the state’s SFA/SEDESA. solved by MAPA.

ANNEX II 108 BUFFERED BRUCELLA ANTIGEN TEST (BBAT)

MATERIALS REQUIRED 1. The antigen suspension stock must be - antigen for the BBAT ; kept between 4º C and 8º C when not in use; - Bang pipette or 30 μL pipetting device or 2. If the antigen is to be used for a small of adjustable volume; number of tests, it should be divided into por- - pointers; tions, and only the amount to be used each day - plates with delimited 15 mm squares; should be taken out of the refrigerator, so as - plastic, glass, or metal stirrers; to prevent loss of sensitivity owing to repeated - light box with indirect lighting for read- cooling down and warming up. ing; 3. The desirable temperature for test per- - positive control serum; formance should be around 22º C + 4º C; tem- - negative control serum; peratures considerably lower or higher than - plate shaker (optional); and these should be avoided. - minute timer or alarm clock. 4. Plates, stirrers, and pipettes should be PRECAUTIONS DURING TEST cleaned in running water right after use. They PERFORMANCE should be immersed in a neutral detergent solution for two hours, or preferentially over- on each area of the plate; this amount should night. Thereafter they should be washed in run- be deposited on the glass plate by touching the ning water, then in distilled water, and be dried pipette’s tip on the plate at a 45º angle. in an oven or at room temperature. 4. Lightly agitate the antigen and place 30 5. Hemolysed serums should be discarded μL of it next to the serum, without mixing. as they may yield false positive results. 5. Using a simple or multiple mixer, mix 6. Parallel testing of positive and negative the serum and the antigen by making circular control samples should be done in connection movements until a circle of approximately 2 cm with all tests. in diameter is obtained. METHOD: 6. Agitate the plate with oscillating move- 1. Serums and antigens should be kept in ments at a rate of approximately 30 (thirty) equilibrium at 22º C + 4º C for at last 30 min- movements per minute so as to allow the anti- utes. If serums are frozen, the equilibrium gen mixture to slowly flow into each circle. The period at room temperature must be longer. plate must be agitated continuously for four Serums should be homogenized before test is minutes. performed. 7. Place the plate in the reading box with 2. Test forms identifying the location of indirect lighting and read. each serum should be filled out. 8. Write down the results. 3. During utilization of a 30 μL pipetting 9. Ignore any agglutinating reactions that device or of a Bang pipette equipped with a may occur after the four minutes. rubber bulb, or another pipetting device to prevent the use of the mouth, 30 μL of serum INTERPRETATION OF RESULTS (or serum measured from the 0.04 to the 0.01 Presence of granules – REACTIVE mark on the Bang pipette) should be dispensed Absence of granules – NON-REACTIVE

ANNEX III

2-MERCAPTOETHANOL (2-ME) TEST 109 MATERIALS: 10 ml pipettes; antigen for slow tube seroagglutination light box with indirect lighting for reading (SAT); results; 2 Mercaptoethanol (2-ME); hot air oven at 37º C; and 0.85-percent saline solution; glass vessels for diluting reactants. 0.5-percent saline-phenicate solution; PRECAUTIONS DURING TEST Serum samples to be tested; PERFORMANCE high-titer positive control serum; 1. The antigen for the series of tubes should medium-titer positive control serum; be diluted with 2-ME in an 0.85-percent saline low-titer positive control serum; solution without the addition of phenol; negative control serum; 2. It is recommended that the antigen dilu- 10 mm x 75 mm or 10 mm x 100 mm tion be done 12 (twelve) hours before use; tubes; 3. Diluted antigens should be kept under tube rack; refrigeration (+4º C - +8º C) and may be used Bang pipettes or adjustable volume mi- for up to one week; cropipetting devices; 4. 2-ME should be kept in tightly-closed 1 ml automatic dispenser; amber-colored vessels under refrigeration; 2 ml automatic dispenser; 5. 2-ME is toxic for humans and should be kept in a gas exhaustion cabinet; 8. With the pipette at the bottom of the first 6. For each day of work at least on selected tube of the first row, let 0.08 ml of serum flow serum should be included, especially one with out. Deposit 0.04 ml into the second tube, 0.02 a high anti-Brucella IgM antibodies content and ml into the third, and 0.01 into the fourth; that does not contain IGg detectable through 9. Repeat the procedure to deposit the the 2-ME test, as well as other serum that is re- same serum amounts into the tubes of the sec- active under SAT and 2-ME; ond row (the 2-ME series); 7. Each test should also include antigen 10. Repeat the procedure for all serum control tubes with positive-tested serums of samples in a similar way, pipetting serum into known titer, and negative serum; and every properly identified rows of tubes; 8. The 2-ME test is incubated and read to- 11. Identify the positive control serums of gether with SAT. Occasionally, the 1:25 dilution known agglutinating activity; tube may seem somewhat opaque in the 2-ME 12. Include the negative control serum into test, even though the following tubes are clear. the 2-ME test; This should not be considered as a negative re- 13. With the 2 ml automatic dispenser, or sult of the test. with a 10 ml-pipette, add to each of the four METHOD tubes of the T row 2 ml of the antigen diluted 1. Dilute the antigen for SAT in tubes 100 at 1:100 (0.045 percent of cells ) in a saline- (one hundred) times in a 0.85 percent saline phenicate solution; solution containing 0.5 percent phenol. Final 14. With the 2 ml automatic dispenser (ad- concentration: 0.045 percent; justed to 1 ml), or a 10 ml-pipette, add 1 ml of 2. Dilute the antigen for the 2-ME test in 0.1 M 2-ME solution (diluted in a solution with- tubes 50 (fifty) times in a 0.85-percent saline out phenol) to each tube of the M row; solution without addition of phenol. Final con- 15. Mix well by shaking the rack; centration: 0.090 percent; 16. Let racks with samples rest for 30 (thir- 3. Prepare the 0.1M 2-ME solution, mixing ty) minutes at room temperature; 7.8 ml of 2-ME into a 992.20 ml of a 0.85-per- 17. After 30 (thirty) minutes, using the au- cent saline solution without phenol, or in pro- tomatic pipetting device or another 10 ml pi- portionately smaller volumes; pette, add to each tube in row M 1 ml of the 4. Place two rows of four tubes in a tube antigen diluted at 1:50 (0.09 percent of cells) in 110 rack for each test; a saline solution (without phenol); 5. Identify the first tube of each row with 18. Mix well by agitating the rack; the number of the serum to be tested; 19. Incubate at 37º C (thirty-seven degrees 6. The first row corresponds to the four di- centigrade) for 48 hours + three hours; lutions of the SAT serum and should be marked 20. Test reading is done under indirect with the letter “T”. The second row to be sub- lighting against a dark, opaque background, jected to the 2-ME test should be marked with as bright light shines through the tubes. Other the letter “M”; sources of light should be dimmed. Interpreta- 7. With a Bang pipette provided with a tion is based on the cloudiness in the tubes and rubber bulb or some other pipetting device to the firmness of granules after a slight agitation avoid the use of the mouth, transfer the serum of the tubes (antigen agglutination); until it reaches a slightly higher mark. Clean 21. Write down the results. If there is inter- the pipette’s tip with absorbent paper; Keep- est in determining a serum’s final titer, the se- ing the pipette in a vertical position against the rial dilutions method may be employed. wall of the tube containing the sample, let the INTERPRETATION OF RESULTS serum trickle in until the bottom of the piston The extent of agglutination in each of the stroke inside the pipette is level with its highest different solutions should be classified as: com- mark; plete (+), incomplete (I), or negative (-): Complete reaction: the serum-antigen Negative reaction: the serum-antigen mix- mixture is clear, and a slight agitation does not ture is opaque or cloudy, and a slight agitation break down the granules; does not show any granules. Incomplete reaction: the serum-antigen mixture is partially clear, and a slight agitation Interpretation of the test results is based does not break down the granules; on tables 1 and 2 below:

TABLE 1: Interpretation of the 2-ME test of females aged 24 months or over and vaccinated between three and eight months of age

2-ME SAT NR 25 I 25 50 I 50 100 I 100 200 I 200 NR - 25 I - - 25 - - + 50 I - - + + 50 - - + + + 100 I - - + + + + 100 Inc Inc + + + + + 200 I Inc Inc + + + + + + 200 Inc Inc + + + + + + +

+: positive - : negative SAT = Slow Agglutination Test 2-ME = 2-Mercaptoethanol Test NR = nonreactive I = incomplete reaction Inc = inconclusive reaction 111 – Combination that should not occur TABLE 2: Interpretation of the 2-ME test of unvaccinated females and males over 8 (eight) months of age.

2-ME SAT NR 25 I 25 50 I 50 100 I 100 200 I 200 NR - 25 I - - 25 - - + 50 I - - + + 50 Inc Inc + + + 100 I Inc Inc + + + + 100 Inc Inc + + + + + 200 I Inc Inc + + + + + + 200 Inc Inc + + + + + + +

+: positive - : negative SAT = Slow Agglutination Test 2-ME = 2-Mercaptoethanol Test NR = nonreactive I = incomplete reaction Inc = inconclusive reaction – Combination that should not occur

ANNEX IV

MILK RING TEST (MRT) 112 MATERIALS: mation of the cream layer on the milk surface. antigen for the Milk Ring Test; 3. Heating the milk above 45º C (forty-five milk samples to be tested; degrees centigrade) reduces the quantity of anti- 10 mm x 75 mm or 10 mm x 100 mm tubes Brucella antibodies in the sample. tube rack 4. Freezing or pasteurizing the sample may 1 ml pipettes yield false-negative results; such samples should 30 µl pipetting device; and not be used in the MRT. Hot air oven or steam bath at 37º C (thirty- 5. Acid milk, recently collected milk, milk seven degrees centigrade). containing colostrum, cow milk from the drying- PRECAUTIONS DURING TEST PERFOR- up period and from cows with mamitis may yield MANCE false-positive results. 1. Milk samples should be kept between +2º 6. The herd’s size may influence test results C and +8º C for at least 24 (twenty-four) hours when the milk is collected in milk cans. In this before the MRT. case, the quantity of milk to be used in the test 2. Excessive agitation of milk samples breaks should be increased according to the following down fat globules, which interferes with the for- table: Nº of animals Milk volume (in ml) Up to 150 1 151 – 450 2 451 – 700 3 Over 700 Divided into smaller batches

7. Parallel testing of positive and negative PRECAUTIONS DURING TEST control samples should be done in connection PERFORMANCE; with all tests. 4. Add 30 µl of antigen to the milk; METHOD 5. Put lid on the tube and mix the contents 1. Keep milk samples and the antigen at a by inverting the tube several times; temperature of 22º C (twenty two degrees cen- 6. Let it rest for one minute and check if mix- tigrade ) + 4º C (four degrees centigrade) for at ture is homogenous. No antigen should be cling- least 60 (sixty) minutes; ing to the wall of the tube; 2. Mix milk samples well; 7. Incubate for one hour at 37º C (thirty-sev- 3. Deposit 1 ml of milk into 10 mm x 1000 en degrees centigrade); mm tubes. The milk column should be at least 2 8. Proceed with the reading; cm (two centimeters) high. 9. Write down the results. Observation: Depending on the herd’s size, INTERPRETATION OF RESULTS: the amount of milk to be used in the test (for A blue cream ring and white or bluish milk the same antigen amount – 30 µl) should be in- column: REACTIVE creased to 2 ml or 3 ml (two or three ml) as rec- A white cream ring and blue milk column: ommended under item 6 NONREACTIVE

113 ANNEX V

MODEL FORM FOR FORWARDING SAMPLES FOR BRUCELLOSIS DIAGNOSTIC

Space reserved for laboratory use. Sample condition at reception: ( ) Frozen ( ) Chilled Date: ___/___/___ ( ) Satisfactory ( ) Unsatisfactory Received by:

I – REQUESTER’S INFORMATION 1. Name: 2. CRMV No.: Qualification Document 3. Address: District: Municipality: State: Postal Code: 4. Telephone: Fax: 5. E-mail: 6. Carrier: ( ) Yes ( ) No

II – CARRIER’S INFORMATION (IF OTHER THAN THE REQUESTER) 1. Name: 2. CRMV No.: Qualification Document: 3. Address: District: Municipality: State: Postal Code: 4. Telephone: Fax: 5. E-mail:

III – SAMPLE INFORMATION 1. Collection data: ___/___/___ 2. Reason for test: 114 3. Number of animals from which sample was collected * 4. Animal’s origin: Property: Owner: Municipality: Location: 5. Species: Breed: 6. Gender: Age: 7. Vaccinated animal:: ( ) Yes ( ) No. ( ) Don’t know Date: ___/___/___ 8. Abortion on the Property: ( ) Yes ( ) No. ( ) Don’t know 9. Serologic tests : ( ) Yes When: ___/___/___ Which ones: 10. Serologic test results: 11. History:

* In case samples are destined for MRT. ANNEX VI

MODEL OF FORM FOR DESIGNATING A CARRIER

DESIGNATION OF A CARRIER

I, , a Veterinary Doctor, CRMV Registration (full name) No. . in the state of , bearer of Qualification No. , (UF) (habilitação) hereby designate (nome completo) Bearer of I.D. No. , as carrier of sample(s) of blood / milk by

me collected and identified pursuant to Requests No.

Place and date: , _____/_____/______

Veterinary Doctor

Signature and seal

ANNEX VII

MODEL OF FORM FOR RETESTING REQUEST

RETESTING REQUEST 115 To the SFA Chief / State (Please specify)

I, ______, a Veterinary Doctor, CRMV Registration No. ______in the (Full name) state of ______, bearer of Qualification No. ______, hereby request the start of procedures for

the retesting of the samples registered under No. ______of the series No. ______, at the Laboratory

______, located in the city of ______(Laboratory’s name) JUSTIFICATION: ______

______

(signature: Veterinary doctor / interested party)

Date

of ______, bearer of Qualification No. ______, hereby ____/_____/_____ ANNEX VIII

REPORT ON BRUCELLOSIS DIAGNOSTIC OPERATING ACTIVITIES

MONTH / YEAR

Laboratory: Veterinarian in charge:

Accreditation Administrative Ruling No.: CRMV Registration No.

Brucellosis Antigen Lab: Lot (s): Validity: Doses purchased Used: Losses: Stock

TESTS PERFORMED

Owner/Property Municipality/ Test type* No. of animals No. of negatives No. of positives State tested

*1 - BBAT 2 – 2-ME 116 3 - MRT

ANNEX IX

MODEL OF LOG FOR THE RECORDING OF SAMPLES FOR BRUCELLOSIS DIAGNOSTIC

DATE REGISTRATION REQUEST ANIMAL’S MUNICIPALITY OWNER PROPERTY TYPE RESULT DATE OBS No. SERIAL No. NAME OR OF No. EXAM ANNEX X

MODEL OF CERTIFICATE OF THE PERFORMANCE OF BRUCELLOSIS TEST

Accreditation Administrative Ruling No. Lab identification:

Owner: Property: Municipality: State: No. brucellosis tests Species: Collection date: ___/___/___ Test date: ___/___/___ Antigen: Laboratory: Lot: Manufacturing date: Collected by Vet. Dr. CRMV Qualification No. Reason for testing:

No. Identidication Gender Age Breed Test Vaccination Vaccination Interpretation Diagnostic date BBAT SAT 2-ME

1 2 3 4 5 6 7 8 9 10 11 117 12 13 14 15 16 17 18 19 20 NORMATIVE INSTRUCTION No. 30 OF JUNE 7, 2006

Published in the Official Gazette of June 16, 2006, Section 1, Page 5

Establishes norms for the qualification of private sector veterinary doctors for carrying out the activities contemplated under the Technical Regulations of the National Program for the Control and Eradication of Animal Brucellosis and Tuberculosis-PNCEBT, as regards performing brucellosis and tuberculosis diagnostic tests, forwarding samples to accredited laboratories, and participating in the certification of raising establishments free of or monitored for bovine and bubaline brucellosis and tuberculosis.

THE MINISTRY OF AGRICULTURE, LIVESTOCK the State(s) where he intends to work, by filling AND FOOD SUPPLY’S AGRICULTURE AND LIVE- out the forms shown in Annexes I and II. The STOCK HEALTH AND INSPECTION SECRETARY, by State service will evaluate whether the applicant virtue of the powers vested in him under Art. meets the established requirements and submit 42 of Annex I to Decree No. 5351 of January 21, the proceeding to the State’s Federal Agriculture 2005, having in view the provisions under Art. Superintendence, which will issue the qualifica- 2 of Ministerial Normative Instruction No. 2 of tion decision. January 10, 2001, and Art. 3. The qualification shall be valid in the Having in view Chapter X of the Technical State(s) for which the veterinary doctor has been Regulations of the National Program on the Con- qualified. trol and Eradication of Animal Brucellosis and Art. 4. To be qualified, the veterinary doctor Tuberculosis-PNCEBT approved under SDA Nor- must meet the following requirements: mative Instruction No. 6 of January 8, 2004, and I – Be registered with the Regional Veterinary Proceeding No. 21000.004861/2005-50, Medicine Council (CRMV) of the State(s) where he RESOLVES: will work; Art. 1. To establish norms for the qualifi- II – Submit to the Local Unit of the animal cation of veterinarian doctors from the private health and Inspection service of the State(s) where 118 sector for carrying out activities contemplated he intends to work a registered certificate of hav- under the Technical Regulations of the Nation- ing successfully concluded the “Training Course on al Program on the Control and Eradication of Methods of Animal Brucellosis and Tuberculosis Animal Brucellosis and Tuberculosis-PNCEBT, in Diagnostic and Control and on Notions of Trans- connection with the performance of brucellosis missible Spongiform Encephalopathy” accredited and tuberculosis diagnostic tests, to the forward- by the Animal Health Department, or a certificate ing of samples to accredited laboratories, and to of participation in a “Seminar on Standardization participation in the process for the certification of Courses on Methods of Animal Brucellosis and of livestock establishments free of bovine and Tuberculosis Diagnostic and Control,” issued by bubaline brucellosis and tuberculosis or moni- the Animal Health Department; and tored in regard to these diseases, pursuant to the III – Have at his disposal the appropriate in- Annexes hereto. frastructure and materials for the performance Sole Paragraph. The qualification of veteri- of brucellosis and tuberculosis diagnostic tests, in nary doctors from the official animal health and accordance with the following: inspection service is hereby prohibited. a) 1. For the performance of the brucel- Art. 2. The interested veterinary doctor losis test, veterinary doctors must also have the should apply for qualification to the local unit following items available: climatized environ- of the animal health and Inspection service of ment (controlled temperature at 22º C ± 4º C), a water supply point; refrigerator with freezer, or bility for vaccination, a veterinary doctor must refrigerator and freezer; automatic or adjust- be registered with the respective State’s official able 30 µl pipetting device; indirect lighting; animal health and inspection service, pursuant chronometer; agglutination glass plate; blood to PNCEBT Technical Regulations. collection material; irons to brand positive re- Art. 6. An accredited veterinary doctor shall: active animals; and certificate forms; I – Comply with the PNCEBT Technical Regu- 2. For the performance of the milk ring test: lations and other complementary norms estab- 10 mm x 75 mm or 10 mm x 100 mm tubes; tube lished by the Animal Health and Inspection De- rack; 1 ml pipettes; oven or bain-marie at 37 º C partment and by the official animal health and (thirty-seven degrees centigrade); inspection service of the State for which he has b) For tuberculosis diagnostic: at least two been qualified; multi-dose syringes for applying tuberculin on II – Provide information related to the Pro- cattle set for 0.1 ml and equipped with appropri- gram and submit one copy of the brucellosis and ate needles for intradermal inoculation; specific tuberculosis tests’ performance (Annex III) to the caliper for bovine tuberculin testing graduated Local Unit of the Municipality’s official animal on a scale of tenths of millimeters; tricotomy de- health and Inspection service where the estab- vice; iron for branding positive reactive animals; lishment serviced is located, on a monthly basis, certificate forms; by the fifth day of the following month; c) At the official animal health and Inspec- III – Submit a monthly report by the fifth day tion service’s discretion, the requirement per- of the following month on the use of antigens taining to the facilities and equipment listed in and tuberculin to the official animal health and (a)1 and (a)2 above may be waived, except for inspection service of the jurisdiction where these the items for blood collection and for branding items were acquired (Annex IV); positive reactive animals, provided the veterinary IV – Record all tuberculosis test results on doctor states that he will forward the brucellosis the appropriate form (Annex V), which may be diagnostic samples solely to accredited [private] requested by the official animal health and in- laboratories or accredited official laboratories. In spection service at any time; this case, the veterinary doctor is barred from ac- V – To brand positive animals with the let- quiring antigens and from performing diagnostic ter “P” pursuant to PNCEBT Technical Regulations tests for brucellosis and becomes responsible for and take steps toward the correct elimination of 119 issuing this test’s performance certificate (Annex such animals; III ), to which must be attached the test results is- VI – Notify positive results within one busi- sued by the accredited laboratory in question; ness day to the Local Unit of the Municipality’s of- d) At the official animal health and Inspec- ficial animal health and inspection service where tion service’s discretion, up to five veterinary doc- the livestock establishment is located; and tors that work in formal societies or cooperatives VII – To respond to calls from the official ser- may be accepted for qualification, provided they vice. share facilities and equipment listed under items Art. 7. The State’s official animal health and (a) and (a)1 for brucellosis diagnostic; and inspection service may, under its own legislation, e) At the official animal health and Inspec- establish the sanctions applicable to accredited tion service’s discretion, up to five veterinary doc- veterinary doctors that fail to comply with items tors that work in formal societies or cooperatives I, II, III, IV, V, VI, and VII of the preceding Art. 6. may be accepted for qualification, provided they Art. 8. The dispensing of antigens and tu- share syringes and calipers for tuberculosis diag- berculin to veterinary doctors in noncompliance nostic, as described under item (b) above. with the provisions of Art. 6 hereunder is hereby Art. 5. For the purposes of issuing a pre- automatically suspended, pending regularization scription for the acquisition of vaccines against of their situation. brucellosis and of assuming technical responsi- Art. 9. At the official animal health and inspection service’s discretion, the collection of two Livestock, and Food Supply, or by the State’s offi- blood samples may be officially overseen, one of cial animal health and inspection service. In such which shall be destined for an accredited official a case, the veterinary doctor may apply again for laboratory; inoculation and the reading of tuber- qualification only one year after cancellation. At culosis test results may also be officially overseen. the official service’s discretion, new qualification To this end, the health and inspection body may may me granted or denied, depending primarily require prior notice of the date of the accredited on the type of noncompliance; and veterinary doctors’ visits to the properties. II –The veterinary doctor may apply again Art. 10. Qualification may be cancelled as at any time, pursuant to the procedures here- follows: under. I – At the State’s official animal health and in- Art. 11. This Normative Instruction shall en- spection service or the State’s Federal Agricultural ter into force on the date of its publication. Superintendence in case of noncompliance with Art. 12. SDA Normative Instructions No. 10 PNCEBT Technical Regulations and other sanitary of January 15, 2004 and No. 55 of August 4, 2004 norms enacted by the Ministry of Agriculture, are hereby revoked.

GABRIEL ALVES MACIEL

ANNEX I

To the Federal Agricultural Superintendent in the State of ______I, ______, a veterinary doctor, bearer of ______CRMV. No. ______and of Taxpayer ID No. ______, residing at ______, Municipality of ______, State of ______, e-mail ______, without any link to the official animal health and inspection, legally active in my profession in this 120 Sate, hereby apply, pursuant to SDA Normative Instruction No. ______, of ______, 200______, for qualification to perform brucellosis and tuberculosis diagnostic tests, forward samples toac- credited laboratories, and participate in the process of certification of properties free of bovine and bubaline brucellosis and tuberculosis and in the monitoring said diseases in this State. Attachments: proof of registration with this State’s Regional Veterinary Medicine Council; copy of conclusion of the Training Course on Methods of Animal Brucellosis and Tuberculosis Diagnostic and Control and on Notions of Transmissible Spongiform Encephalopathy,” or a certificate of participation in a “Seminar on Standardization of Courses on Methods of Animal Brucellosis and Tuberculosis Diagnostic and Control; and declaration that I am not subject to any ethical or disciplinary proceedings. All listed documents have been duly signed. Respectfully submitted.

______, ______, 200______.

Signed: ______

ANNEX II

DECLARATION I, ______, a veterinary doctor, bearer of ______CRMV No. ______, hereby declare, for the purposes of qualification before the Federal Agricultural Superintendence of the State of ______, that I am not being subjected to any ethical or disciplinary proceeding. I further declare that I shall perform brucellosis diagnostic tests at the following address(es): ______and forward the brucellosis diagnostic samples to an accredited laboratory, thereby being barred from acquiring antigens for the performance of brucellosis tests.

______, ______200_____.

______signed

121 ANNEX III CERTIFICATE OF PERFORMANCE OF BRUCELLOSIS AND TUBERCULOSIS TESTS

Owner: Property: State Registration: Municipality: State: Certificate No.: Total No. of animals: Raising system: Animal breed:

Motive for testing: Movement-Agglomeration- Certificate of Free Property – Certificate of Monitored Property-Other

Number of brucellosis tests:: Sampling date: Test date: Number of tuberculosis tests: Inoculation date: Reading date:

Buffered Brucella antigen Laboratory: Lot: Manufacturing date: test: Bovine PPD: Laboratory: Lot: Manufacturing Date: Avian PPD: Laboratory: Lot: Manufacturing Date:

Animal’s Gender Age Breed Brucellosis result Tuberculosis result Reactants’ number destination BBAT 2-ME CF SCT 1 CITT 1 PCT 3

1 2 3 4 5 6 7 8 122 9 10 11 12 13 14 15 16 17 18 19 20 21 22 ANNEX IV REPORT ON THE USE OF ANTIGENS AND TUBERCULIN FOR BRUCELLOSIS AND TUBERCULOSIS DIAGNOSTIC BY ACCREDITED VETERINARY DOCTORS MONTH / Year

Veterinary doctor: CRMV: Qualification:

Signature:

Brucellosis Lab: Lot(s) Expiration date: Doses acquired: Used: Lost: In stock: antigen Tuberculine Avian Lab: Lot(s) Expiration date: Doses acquired: Used: Lost: In stock: PPD Bovine Lab: Lot(s)) Expiration date: Doses acquired: Used: Lost: In stock:

BRUCELLOSIS TESTS Owner / Property Municipality/ No. of animals No. No. No. positives sent to: State tested negative positive M F M F M F Complementary Sanitary slaughter/ test(s) sacrifice and destruction

TUBERCULOSIS TESTS Owner / Municipality/ No. of animals No. No. No. No. positives sent to: Property State tested negative positive inconclusive 123 M F M F M F M F Complementary Sanitary test(s) slaughter/ sacrifice and destruction

OBS: Slots not filled-out should be crossed out. ANNEX V

TUBERCULINE TESTED ANIMALS’ CONTROL SHEET

Owner: Property: Municipality: State: Certificate No.: Veterinary Doctor: CRMV No.: Qualification: Date of tuberculin inoculation:

Animal No. Aviary Tuberculin (mm) Bovine Tuberculin (mm) AB-AA (mm) Test result A0 A72h AA(A72-A0) B0 B72H AB (B72-B0) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 124 15 16 17 18 19 20

Observations:

Place and date:

signature and seal NORMATIVE INSTRUCTION No. 6 OF JANUARY 8, 2004

Published on the Union Official Journal of January 12, 2004, Section 1, Page 6 Amended by Normative Instruction 59 of August 24,2004

Approves the Technical Regulations of the the National Program for the Control and Eradica- tion of Animal Brucellosis and Tuberculosis.

THE SECRETARY OF ANIMAL AND PLANT or research institutions, private sector veterinar- HEALTH AND INSPECTION OF THE MINISTRY OF ians and laboratories outside the Ministry of Agri- AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, ex- culture, Livestock and Food Supply network, and ercising the powers conferred upon him by Article the contents of Proceedings 21000.012771/2003- 15, subsection II of Decree 4629 of March 21st, 71, resolves to: 2003, in view of the provisions contained in the Art. 1. Approve the Technical Regulations Animal Health and Inspection Service regulations pertaining to the National Program for the Con- approved by Decree 24,548 of July 3rd, 1934, trol and Eradication of Animal Brucellosis and Accounting the need to standardize and guar- Tuberculosis. antee the quality of the instruments and actions Art. 2. Subdelegate to the Director of the of prophylaxis, diagnosis and sanitation of herds, Animal Health and Inspection Department the and of active sanitary surveillance pertaining to competence, as appropriate, to issue legal acts the labors against brucellosis and tuberculosis, supplementary to this Regulation. Accounting the need to define the role of Art. 3. This Normative Instruction shall enter public animal health and inspection bodies in into force on the date of its publication. the fight against these diseases and the integra- Art. 4. Normative Instruction SDA 2 of Janu- tion of such bodies with cattle breeders, teaching ary 10th, 2001 is hereby revoked.

MAÇAO TADANO

APPENDIX 125

TECHNICAL REGULATIONS PERTAINING TO THE NATIONAL PROGRAM FOR THE CONTROL AND ERADICATION OF ANIMAL BRUCELLOSIS AND TUBERCULOSIS

CHAPTER I causes granulomatous lesions, and affects mainly the bovine and bubaline species; DEFINITIONS III – official health service: animal health service on the federal, state or municipal level; Art. 1. For the purposes of this Regulation, IV – local official health service unit: state the following definitions shall be considered: official animal health service office coordinated I - brucellosis: a zoonosis caused by micro- by an official veterinarian, and responsible for organism Brucella abortus, which is character- surveillance and veterinary care actions in one or ized by infertility and abortion by the end of more municipal areas; pregnancy, and affects mainly the bovine and V – official inspection service: animal prod- bubaline species; ucts inspection service on the federal, state and II - tuberculosis: a chronic zoonosis caused municipal levels; by microorganism Mycobacterium bovis, which VI - sanitary slaughter: slaughter of animals that reacted to brucellosis or tuberculosis diag- veterinarian who is registered with the state offi- nostic tests, carried out in an establishment un- cial defence service to carry out vaccination against der official inspection service, in accordance with brucellosis and other activities provided for in the the pertinent legislation; National Program for the Control and Eradication VII - sacrifice and destruction: elimination of of Brucellosis and Animal Tuberculosis; animals that reacted to tests to diagnose brucellosis XVII – accredited veterinarian: a private sec- or tuberculosis, carried out within the rearing es- tor veterinarian who has been approved in the tablishment itself, following the criteria defined by Training Course on Methods to Diagnose and the Animal Health and Inspection Department; Control Brucellosis and Tuberculosis, recognized VIII – rearing establishment: a place where by the Animal Health and Inspection Depart- cattle and buffalo are reared under ordinary han- ment, therefore being able to carry out certain dling conditions; activities as provided for in the National Program IX – rearing establishment undergoing certi- for the Control and Eradication of Animal Brucel- fication: a rearing establishment that is comply- losis and Tuberculosis, under supervision of the ing with the sanitation procedures provided for state and the federal official health service; in this Regulation, with the purpose of obtaining XVIII – official veterinarian: a veterinarian a brucellosis- and tuberculosis-free certificate; working at official health service; X – brucellosis-free rearing establishment: XIX - owner: anyone who is a possessor, a rearing establishment that has obtained a trustee, or in any capacity keeps cattle or buffalo brucellosis-free certificate after concluding sani- under their control or guard; tation procedures against the disease, and that XX - herd: group of animals reared under or- keeps a diagnosis routine as provided for in this dinary handling conditions, at the same rearing Regulation; establishment; XI – tuberculosis-free rearing establishment: XXI – general herd animals: animals not reg- a rearing establishment that has obtained a tu- istered with any bodies recognized by the Minis- berculosis-free certificate after concluding sani- try of Agriculture, Livestock and Food Supply; tation procedures against the disease, and that XXII – registered animals: animals which keeps a diagnosis routine as provided for in this have zootechnical value and are registered with Regulation; bodies recognized by the Ministry of Agriculture, XII – rearing establishment monitored for Livestock and Food Supply; 126 brucellosis and tuberculosis: a farm that keeps XXIII – routine test: the first diagnosis test a diagnosis routine for females aged 24 (twenty- for brucellosis and tuberculosis, usually involving four) months and over, as well as for bulls, as pro- large numbers of animals with unknown sanitary vided for in this Regulation; conditions for these diseases, with the objective of XIII – accredited laboratory: a laboratory identifying any animals suspected of carrying an accredited by the Animal Health and Inspection infection, or of obtaining a conclusive diagnosis; Department by delegation of competence to XXIV – confirmation test(s): one or more tests perform laboratorial diagnosis for brucellosis or used to obtain a conclusive diagnosis for animals tuberculosis; that had previously reacted to routine tests; XIV – official accredited laboratory: a labo- XXV – herd test: one or more diagnosis tests ratory in a federal, state or municipal institution performed on an entire herd, except for any ani- that has been accredited by the Animal Health mals that may not be submitted to any diagnosis and Inspection Department to perform laborato- tests for brucellosis or tuberculosis, in accordance rial diagnosis for brucellosis or tuberculosis; with this Regulation; XV – reference laboratory: a laboratory that XXVI - prevalence: total number of infected is part of the Ministry of Agriculture, Livestock animals at a certain moment, divided by the total and Food Supply network; number of animals at risk of acquiring the infec- XVI – registered veterinarian: a private sector tion, at the same moment; XXVII - incidence: number of new cases of III – voluntary certification of brucellosis- infected animals in a certain population, during and tuberculosis-free rearing establishments, a specified period of time; where rigorous sanitation and active sanitary XXVIII – diagnosis sensitivity: capacity of a surveillance measures are applied, which will diagnosis test to classify infected animals as posi- contribute to fight the diseases and improve the tive for a disease. sanitary standards of animal products, especially XXIX – diagnosis specificity: capacity of a di- milk and derivatives, and to add value to live- agnosis test to classify non-infected animals as stock products; negative for a disease. IV – voluntary certification of rearing establishments monitored for brucellosis and tuber- CHAPTER II culosis, with the same objectives defined in the above numeral, however using risk management OBJECTIVES OF THE PROGRAM procedures adapted to the handling conditions AND OPERATIONS STRATEGY and to the size of the beef herds. Art. 4. The official health service will qual- Art. 2. The National Program for the Control ify private sector veterinarians and accredit and Eradication of Brucellosis and Animal Tuber- laboratories outside the Ministry of Agriculture, culosis has the following specific objectives: Livestock and Food Supply network to carry out I – to lower the prevalence and incidence of the activities provided for in this Program, and brucellosis and tuberculosis; it will be necessary to train all professionals II – to certify a large number of rearing es- involved and to standardize the actions devel- tablishments where the control and eradication oped by them. of these diseases are carried out with rigor and Paragraph 1. For the qualification of vet- efficiency, with the aim of increasing the offer of erinarians, specific training courses on diagnosis products posing a low risk to public health. and control methods for brucellosis and tubercu- Art. 3. The operational strategy of the Na- losis offered by teaching or veterinary medicine tional Program for the Control and Eradication research institutions shall be recognized and of Brucellosis and Animal Tuberculosis is based standardized. on the adoption of compulsory animal health Paragraph 2. The Animal Health and Inspec- and inspection procedures, which are supple- tion Department shall accredit private and of- 127 mented by voluntary adhesion measures aim- ficial laboratories to secure adequate diagnosis ing at protecting public health and developing capacity for the needs of this Program. the bases for future actions for the eradication Art. 5. The efficiency of sanitary actions de- of the diseases. With consideration to the epide- pends on the quality and standardization of the miology of brucellosis and tuberculosis, the Pro- diagnosis methods and prophylactic tools used. gram’s sanitary measures are applied especially This Program contemplates and standardizes to cattle and buffalo populations, and we high- techniques available in the country and made light the following: reference to by the World Organization for Animal I – mandatory vaccination against brucello- Health - OIE, and that guarantee the adequate di- sis for females between three and eight months agnosis sensitivity and specificity. The possibility of age, aimed at lowering the prevalence and in- of introducing new diagnosis tests and vaccines cidence of the disease; is expected, so that scientific and technological II – control of the interstate transit of ani- progress may be followed. mals for reproduction and participation of bulls Art. 6. The credibility of the measures pro- and females in exhibitions, fairs, auctions and posed in this Program is directly associated with other agglomerations of animals, with the objec- the monitoring and inspection actions of the tive of avoiding the dissemination of brucellosis official health and inspection service, carried and tuberculosis; out in collaboration with the official inspection service. The official health and inspection ser- Art. 10. Use of the B19 vaccine in males vice will certify the quality and efficiency of the at any age and in females aged over 8 (eight) sanitary measures, by acting at critical points of months is hereby forbidden. the Program. Art. 11. Proof of vaccination of female calves at the local official health service unit, at CHAPTER III least once every semester, is mandatory. Sole Paragraph. Proof of vaccination will VACCINATION AGAINST BRUCELLOSIS take the form of a certificate issued by a registered veterinarian, according to the standards Art. 7. Vaccination of all cattle and buf- and using a model document to be defined by falo females in the age group from three to eight the Animal Health and Inspection Department. months is mandatory. Art. 12. Vaccination of females over eight Paragraph 1. The hot-branding of vaccinat- months old may be authorized using immuno- ed females is mandatory, with a letter V on the gens that do not interfere with the diagnosis left side of the face, according to the following tests, under the conditions defined by the Ani- picture, followed by the last digits of the vac- mal Health and Inspection Department. cination year. Art. 13. The Director of the Animal Health Department may change vaccination strategies and regulations based on the evolution of 3mm the epidemiological situation in the states or part of them.

CHAPTER IV 4cm PRODUCTION, CONTROL AND TRADING OF VACCINES AGAINST BRUCELLOSIS

Art. 14. Production and control of all batches of freeze-dried vaccine shall obey Ani- Paragraph 2. Any females designated for mal Health and Inspection Department stan- 128 Genealogical Registration are excluded from the dards. provisions of Paragraph 1 above, when properly Art. 15. Trading of the vaccine shall require identified, as well as any females identified in- a prescription issued by a registered veterinar- dividually by a system approved by the Ministry ian, which will be retained by the commercial of Agriculture, Livestock and Food Supply. establishment and will remain at the disposal Art. 8. Vaccination will take place under of official health service inspectors. the technical responsibility of a registered vet- Sole Paragraph. The establishment respon- erinarian, using a single dose of live, freeze- sible for trading the vaccine is hereby under ob- dried vaccine, prepared with sample 19 of Bru- ligation to communicate the purchase, sale and cella abortus (B19). stocking of the vaccine, to the local official state Sole Paragraph. In regions where there are defence service unit, using a model document no registered veterinarians or where they do established by the Animal Health and Inspec- not fully cater to Program demand, the official tion Department. health service may take upon itself the techni- Art. 16. The annual demand of vaccines in cal responsibility for the vaccination or even each state must be notified by the state official carry out the vaccination. health and inspection service to the federal of- Art. 9. The registration of veterinarians ficial defence service in the state, up to Novem- shall be free of charge. ber of the previous year. CHAPTER V lation and follow the supplementary recommendations given by the Animal Health and PRODUCTION, CONTROL AND Inspection Department. DISTRIBUTION OF ANTIGENS FOR Art. 20. The serological diagnosis tests for THE DIAGNOSIS OF BRUCELLOSIS brucellosis will be performed on: I – females aged 24 months or up, vaccinat- Art. 17. The antigens to be used in serolog- ed at between three and eight months of age; ical tests for the diagnosis of brucellosis shall be II – non-vaccinated females and males over the buffered acidified antigen, the slow serum eight months old. agglutination antigen and the milk ring test an- Paragraph 1. Any females submitted to se- tigen, produced and controlled according to the rological diagnosis tests for brucellosis within a standards approved by the Animal Health and 15 day period before giving birth to within a 15 Inspection Department. day period after giving birth must be retested Sole Paragraph. Other antigens may be within 30 to 60 days after giving birth. used for the diagnosis of brucellosis after the Paragraph 2. Castrated animals are here- approval of and under the conditions defined by excluded from serological diagnosis tests by the Animal Health and Inspection Depart- for brucellosis. ment. Art. 21. The Buffered Brucella antigen test Art. 18. The distribution of antigens shall (BBAT ) test will be used as a routine test, ac- be controlled by the official health service, and cording to the following conditions and crite- they shall be supplied only to accredited vet- ria: erinarians, accredited laboratories, accredited I – it must be performed by a accredited official laboratories and teaching and research veterinarian, accredited laboratory, accredited institutions. official laboratories or, up to July 31, 2005 Paragraph 1. The accredited veterinarian (changed by Normative Instruction No.59 of au- responsible for obtaining the antigen shall sup- gust 24, 2004), by a registered veterinarian; ply the official health service with an official us- II – the presence of any agglutination will age report, under the conditions to be defined classify the animal as reacting to the test; by the Animal Health Department. III – non-reacting animals are considered Paragraph 2. From the date of publication negative for the disease; 129 of this Regulation until July 31, 2005 (changed IV – reacting animals may be submitted by Normative Instruction No. 59 of august 24, to a confirmation test or be sent for sanitary 2004) registered veterinarians shall be autho- slaughter or sacrifice and destruction, at the rized to obtain antigen for serological diagnosis accredited veterinarian’s discretion, as provid- of brucellosis, all conditions established by the ed for in Chapter IX. Animal Health Department respected. Art. 22. The 2-Mercaptoethanol (2-ME) test will be used as a confirmation test for animals CHAPTER VI reacting to the BBAT test, according to the following conditions and criteria: INDIRECT DIAGNOSIS OF BRUCELLOSIS I – to be performed by an accredited laboratory or an accredited official laboratory; Art. 19. The performance of indirect diag- II – the interpretation of the test will obey nosis tests for brucellosis must obey this Regu- Tables 1 and 2: Table 1. Interpretation of 2-ME test for females aged 24 months and up, vaccinated at between three and eight months of age.

Slow seroagglutination test (UI/ml) 2-ME Test (UI/ml) Interpretation < 50 < 25 Negative < 100 < 25 Inconclusive < 25 < 25 Positive UI - (International Unit)

Table 2. Interpretation of 2-ME test for non-vaccinated females and males aged over eight months old.

Slow seroagglutination test (UI/ml) 2-ME Test (UI/ml) Interpretation < 25 < 25 Negative < 50 < 25 Inconclusive < 25 < 25 Positive UI - (International Unit)

III – according to the accredited veterinar- ments certified as brucellosis-free or for other ian’s decision, animals reacting inconclusively purposes according to criteria laid down by the can be: official health service. a) subjected to the complement fixation Paragraph 1. The test result is considered test; or positive when the intensity of the ring color is b) retested after an interval of 30 to 60 days, equal to or superior to that of the milk column. using the 2-ME test, and classified as reacting Paragraph 2. The test result is considered positive if upon being retested they present a negative when the intensity of the ring color is inferior to that of the milk column. 130 positive result or second inconclusive result; or c) sent for sanitary slaughter or sacrifice Paragraph 3. In cases of positive results, the and destruction, according to the provisions of animals in the rearing establishment must be Chapter IX. tested individually for brucellosis. Art. 23. The Complement Fixation Test will Art. 25. Other diagnosis tests for brucel- be used as a confirmation test, to be performed losis can be used to supplement or substitute and interpreted according to recommendations the tests specified in Articles 21, 22, 23 and 24, by the Animal Health and Inspection Depart- after the approval of and under the conditions ment, and it must be: established by the Animal Health and Inspection I – performed by an accredited official labo- Department. ratory; II – used for the international animal move- CHAPTER VII ment; III – used as a test for animals reacting to PRODUCTION, CONTROL AND the BBAT test or for animals who had an incon- DISTRIBUTION OF TUBERCULIN clusive result to the 2ME test. Art. 24. The Milk Ring Test (MRT) may be Art. 26. Only bovine and avian PPD (Purified used by the official health service or by a accred- Protein Derived) tuberculin produced and con- ited veterinarian to monitor rearing establish- trolled in accordance with Animal Health and Inspection Department standards shall be used. days before giving birth until a period of 15 days Art. 27. Controlling the distribution of tu- after giving birth must be retested within 60 to berculin will fall under the responsibility of the 90 days after giving birth. A minimum interval of official health service, which will supply it only 60 days between tests must be obeyed. to accredited veterinarians and teaching and re- Art. 29. The use of proper tuberculiniza- search institutions. tion material is mandatory, according to the Paragraph 1. The accredited veterinarian in decision of the Animal Health and Inspection charge of obtaining tuberculin must supply the Department. official health service with a usage report, un- Art. 30. The Single Cervical Test (SCT) is the der the conditions to be defined by the Animal recommended routine test, and the following Health and Inspection Department. conditions and criteria must be observed: Paragraph 2. From the date of publication I – it should be performed via an intrader- of this Regulation until July 31, 2005 (changed mal inoculation of 0.1 ml of bovine PPD tuber- by Normative Instruction No. 59 of august 24, culin to the cervical region or the scapular region 2004), registered veterinarians shall be autho- of cattle, to be administered on the same side of rized to obtain tuberculin, all conditions es- all animals in the rearing establishment; tablished by the Animal Health and Inspection II – the inoculation spot will be market by Department respected. the removal of local hair, and skin fold thickness shall be measured with skin fold calipers prior to CHAPTER VIII inoculation; III – after 72 hours ± 6 hours of the inocula- INDIRECT DIAGNOSIS OF TUBERCULOSIS tion, a new measurement of the skin fold where the bovine PPD tuberculin was inoculated shall Art. 28. Indirect diagnosis of tuberculosis be made; shall be obtained via tuberculin delayed hiper- IV – the increase in thickness of the skin sensitivity tests to be performed on cattle and fold (ΔB) shall be calculated by subtracting the buffalo aged six weeks and up by a accredited measure of the skin fold on the day the bovine veterinarian or until July 31, 2005 (changed by PPD tuberculin was inoculated from the mea- Normative Instruction No. 59 of august 24, 2004), sure of the skin fold at 72 hours ± 6 hours after by a registered veterinarian. inoculation; 131 Sole Paragraph. Females submitted to a di- V – the results for cattle will be interpreted agnosis test for tuberculosis within a period of 15 according to Table 3:

Table 3 – Interpretation of cervical test on cattle.

Reactions ΔB (mm) Sensitivity Consistency Other changes Interpretation 0 to 1,9 — — — negative 2,0 to 3,9 little pain hardened delimited inconclusive 2,0 to 3,9 much pain soft exudation, necrosis positive 4,0 — — — positive VI – animals reacting inconclusively or ments where there is occurrence of unspecific re- be considered positive to the test may be sub- actions, establishments certified as free, and for mitted to a confirmation test after an interval buffalo farms, with the purpose of securing good between 60 and 90 days, at the accredited vet- diagnosis specificity, to be used under the follow- erinarian’s discretion, and be sent for sanitary ing conditions and criteria:(changed by Norma- slaughter or sacrifice and destruction, accord- tive Instruction No. 59 of august 24, 2004) ing to the provisions of Chapter IX; I – intradermal inoculation of 0.1 ml dose Art. 31. The caudal fold test (CFT) may be of avian and bovine PPD tuberculin in the used as a routine test exclusively at beef farms cervical region or the scapular region, with a and according to the following conditions and distance of 15 to 20 cm between both inocu- criteria: lations, the avian PPD to be inoculated in the I – intradermal inoculation of 0.1ml dose cranium and the bovine PPD in the tail, making of bovine PPD tuberculin to be administered sure the inoculation is performed on the same six to ten centimeters from the tail base, where side of all animals in the farm; hairy and non-hairy skin join, on the same side II – the inoculation sites are to be marked of the caudal fold of all animals of the rearing by local hair removal, and the skin fold thick- establishment; ness shall be measured with a skin fold caliper II – reading and interpretation of the re- before inoculation; sults shall take place 72 hours ± 6 hours after III – after 72 hours ± 6 hours of the inocu- inoculation of the tuberculin, when the inoculation, a new measurement of the skin fold will lated fold shall be compared with the opposite be made at the inoculation site of the avian fold by visual evaluation and palpation; and bovine PPD tuberculin; III – any increase in thickness of the inocu- IV – the increase in thickness of the skin lated fold will classify the animal as reacting; fold will be calculated by subtracting the mea- IV – reacting animals may be submitted to sure of the skin fold at 72 hours ± 6 hours confirmation tests after an interval of 60 to 90 after inoculation from the measure of the days, or be sent for sanitary slaughter or sacri- skin fold on the day the inoculation of avian fice and destruction at the registered veterinar- PPD tuberculin (ΔA) and bovine PPD tubercu- ian’s discretion according to the provisions of lin (ΔB) took place. The difference in skin fold Chapter IX. increase caused by the inoculation of bovine 132 Art. 32. The comparative intradermal tu- PPD tuberculin (ΔB) and the avian PPD tuber- berculin test (CITT) is the confirmation test per- culin (ΔA) will be calculated by subtracting ΔA formed on animals reacting to the routine tests from ΔB. described in Articles 30 and 31. It is also recom- V – the results of the comparative test in mended as a routine test for rearing establish- cattle shall be interpreted according to Table 4:

Table 4. Interpretation of comparative intradermal tuberculin test on cattle.

B – A (mm) Interpretation B < 2,0 — negative B < A < 0 negative B < A 0,0 to 1,9 negative B < A 2,0 to 3,9 inconclusive B < A < 4,0 positive VI –animals reacting inconclusively may be under official inspection service and nominated subjected to a second comparative intradermal by the federal or state official health service. tuberculin test within a minimum interval of 60 Paragraph 1. Animals reacting positive days between the tests or be considered positive must be immediately removed from dairy and sent for sanitary slaughter or sacrifice and production. destruction at the accredited veterinarian’s discre- Paragraph 2. The official inspection service tion, according to the provisions in Chapter IX; of the establishment where the sanitary slaugh- VII – any animals showing two consecutive ter is to take place shall be notified of the arrival inconclusive results shall be classified as reacting of the animals at least 12 hours in advance, so positive; that the measures provided for in the relevant Art. 33. Other diagnosis tests for tuberculo- legislation may be put to effect. sis may be used to supplement or substitute the Paragraph 3. Animals reacting positive must tests specified on Articles 30, 31 and 32, after ap- be accompanied by an Animal Movement Per- proval and under the conditions established by mit (GTA) upon arrival at the sanitary slaughter the Animal Health and Inspection Department. establishment. The document must inform their positive condition, according to the provisions of Chapter IX the pertinent legislation Art. 36. If the sanitary slaughter at an es- ANIMALS WHITH POSITIVE REACTION tablishment under official inspection service TO THE DIAGNOSIS TESTS FOR nominated by the federal and state official BRUCELLOSIS OR TUBERCULOSIS health service is not possible, the animals shall be sacrificed and destructed at their rearing es- Art. 34. Animals whith positive reaction to tablishment, under the direct inspection of the the diagnosis test for brucellosis or tuberculosis local official health service unit, all procedures shall be hot-branded with iron on the right side established by the Animal Health and Inspection of the face with a “P” contained in a circle eight Department respected. centimeters in diameter, according to the follow- Art. 37. The exit of animals reacting posi- ing figure. tive and of inconclusive reacting animals from the rearing establishment is hereby forbidden, except when they are proven to be headed for 133 sanitary slaughter at an establishment under official inspection service, nominated by the federal or state official health service.

CHAPTER X 3 mm CERTIFICATION AND CAPACITY BUILDING OF VETERINARIANS

4 mm Art. 38. The Federal Agriculture Agencies, together with the state animal health and isn- pection services shall certify private sector vet- 8 cm erinarians for the performance of diagnosis tests and for work in the certification process of farms Art. 35. Animals reacting positive shall in their state. be isolated from the herd and sent to sanitary Art. 39. The accredited veterinarian must: slaughter within a maximum period of 30 (thirty) I – be regularly registered with the Veteri- days following the diagnosis, at an establishment nary Medicine Council of their state; II – have been approved in a Training Course participants may not exceed 20. on Methods to Diagnose and Control Brucello- Art. 44. Any theoretical-practical subjects sis and Tuberculosis recognized by the Animal taught on the Training Course on Methods to Di- Health Department; agnose and Control Brucellosis and Tuberculosis III – comply with this Regulation and other must be in compliance with this Regulation and supplementary standards established by the Ani- other supplementary standards as established by mal Health and Inspection Department; the Animal Health and Inspection Department. IV – have adequate infrastructure and ma- Art. 45. Approval in the Training Course on terial for the performance of diagnosis tests for Methods to Diagnose and Control Brucellosis brucellosis and tuberculosis, as determined by and Tuberculosis is conditioned to passing the the Animal Health Department; theoretical-practical assessment. V – supply information and submit activity Art. 46. The Animal Health and Inspection reports in relation with the National Program Department will hold workshops concerning the for the Control and Eradication of Animal Bru- National Program for the Control and Eradica- cellosis and Tuberculosis, to the local official tion of Animal Brucellosis and Tuberculosis with health service unit, with a frequency and using the objective of certifying teaching veterinarians the model documents established by the Animal for the Training Course on Methods to Diagnose Health and Inspection Department. and Control Brucellosis and Tuberculosis and Art. 40. Certification will be suspended by the standardize procedures. Federal Agriculture Agency in case of non-compliance with this Regulation or with other standards CHAPTER XII established in any sanitary legislation by the Minis- try of Agriculture, Livestock and Food Supply. ACCREDITATION OF LABORATORIES FOR Art. 41. Official veterinarians must be attend THE DIAGNOSIS OF BRUCELLOSIS AND and pass the Training Course on Methods to Di- TUBERCULOSIS agnose and Control Brucellosis and Tuberculosis, recognized by the Animal Health and Inspection Art. 47. The Animal Health and Inspection Department. Department will accredit private laboratories, to which it will delegate activities for the diagnosis CHAPTER XI of brucellosis or tuberculosis, and it will be their 134 role to determine which diagnosis tests are to RECOGNITION OF TRAINING COURSES be performed in these laboratories and what re- FOR THE CERTIFICATION AND CAPACITY quirements are to be fulfilled in order to obtain BUILDING OF VETERINARIANS the accreditation. Art. 48. The Animal Health and Inspection De- Art. 42. Teaching or veterinary medicine re- partment will accredit official laboratories, to which search institutions interested in offering Training it will delegate activities for the diagnosis of brucel- Course on Methods to Diagnose and Control Bru- losis or tuberculosis, and it will be their role to de- cellosis and Tuberculosis with the objective of termine which diagnosis tests are to be performed training and allowing the certification of veteri- in these laboratories and what requirements are to narians who wish to participate in the National be fulfilled in order to obtain the accreditation. Program for the Control and Eradication of Bru- cellosis and Animal Tuberculosis must fulfill all CHAPTER XIII requirements defined by the Animal Health and Inspection Department. REFERENCE LABORATORIES Art. 43. Each Training Course on Methods to Diagnose and Control Brucellosis and Tuberculo- Art. 49. The Animal Health and Inspection sis will last at least 40 hours, and the number of Department shall appoint reference laboratories for brucellosis and tuberculosis, and these shall: vided for in this Regulation; I – be responsible for the production of ref- II – operate under the technical supervision erence brucellosis antigens and tuberculin, or of an accredited veterinarian; tuberculin for use in programs or in exceptional III – use an individual animal identification situations that may be of interest to the Animal system as indicated by the Ministry of Agricul- Health and Inspection Department; ture, Livestock and Food Supply or, if not indi- II – perform direct and indirect diagnosis cated by the Ministry, to adopt their own animal techniques for brucellosis and tuberculosis in identification system, as long as it is approved by situations to be defined by the Animal Health the official health service; and Inspection Department; IV – bear the costs of activities to control III – carry out the official control of batches and eradicate brucellosis and tuberculosis. of brucellosis antigens and tuberculin produced Art. 54. The entrance of animals in rearing in the country; establishments certified as or undergoing certifi- IV – control the quality of the commercial cation as free from brucellosis and tuberculosis vaccines against brucellosis; is conditioned to: V – isolate and perform the epidemiologic I – their being from a brucellosis-free rear- characterization of field samples in situations to ing establishment or the performance of 2 (two) be defined by the Animal Health and Inspection diagnosis tests for brucellosis, complying with Department; the following requirements: VI – perform and collaborate in research a) both tests must have negative results; work and evaluate new diagnosis methods and b) the first test must be performed within new vaccines. a 30 (thirty) day period prior to loading and the Art. 50. The reference laboratories must second test within a 30 (thirty) day period fol- supply standard samples for the production of lowing their entrance in the rearing establish- antigens, allergens and immunogens. ment of destination, with an interval of at least 30 days between tests, and the animals must be CHAPTER XIV kept isolated from the moment they enter the rearing establishment until their second nega- GENERAL PROVISIONS FOR CERTIFIED tive result; REARING ESTABLISHMENTS, OR c) if it is not possible to keep the animals 135 ESTABLISHMENTS UNDERGOING isolated in the rearing establishment of destina- CERTIFICATION, FOR THE CONDITION tion, both tests may be performed during the 60 OF BRUCELLOSIS- AND day period prior to loading, with an interval of TUBERCULOSIS-FREE 30 to 60 days between tests; d) the tests will be performed by an accred- Art. 51. The brucellosis- or tuberculosis-free ited veterinarian, an accredited laboratory or ac- certificate shall be issued by the Federal Agricul- credited official laboratory; ture Agency. e) females up to 24 months of age and vacci- Art. 52. Certification as brucellosis- and tu- nated at between three and eight months of age berculosis-free rearing establishment is adhered may only enter the rearing establishment if they to voluntarily, and it must be formally request are from brucellosis-free rearing establishments. from the local official health service unit where II – their being from a tuberculosis-free the rearing establishment is registered. rearing establishment or the performance of two Art. 53. All rearing establishments certified diagnosis tests for tuberculosis, complying with as or undergoing certification as free from bru- the following requirements: cellosis and tuberculosis are hereby obliged to: a) both tests must have negative results; I – comply with measures to control and b) the first test must be performed within eradicate brucellosis and tuberculosis as pro- a 30 (thirty) day period prior to loading and the second test up to 90 days following their entry in as specified in numeral II, must be overseen by the rearing establishment of destination, with an a state official health service veterinarian, and interval of at least 60 days between tests, and the the tests must be performed at an accredited of- animals must be kept isolated from the moment ficial laboratory. The accredited veterinarian is they enter the establishment until the second responsible for informing the local official health negative result; service unit of the blood sampling date with at c) if it is not possible to keep the animals least 15 days in advance. isolated in the rearing establishment of destination, both tests may be performed during the 90 CHAPTER XVI days that precede their loading, with an interval of at least 60 days between tests; CERTIFICATION AS d) the tests will be performed by a accred- BRUCELLOSIS-FREE REARING E ited veterinarian. STABLISHMENT Art. 55. The official veterinarian may collect biological material to test for brucellosis or Art. 57. The certificate for brucellosis-free tuberculosis, and oversee or perform diagnosis rearing establishment shall be issued by the Fed- tests for tuberculosis at any moment and with- eral Agriculture Agency, on condition that the out burden to the owner, with the objective of following requirements are complied with: verifying and validating the sanitary condition of I – all females between three and eight the certified rearing establishment, or establish- months of age must be vaccinated against bru- ment undergoing certification. cellosis with the B19 vaccine; II – all animals specified in Article 20 must CHAPTER XV be submitted to diagnosis tests for brucellosis; III – three consecutive negative herd tests SANITATION FOR CERTIFICATION AS must be obtained, and performed with an inter- BRUCELLOSIS-FREE REARING val of 90 to 120 days between the first and the ESTABLISHMENT second tests, and 180 to 240 days between the second and third tests. Art. 56. Any rearing establishments under- Art. 58. The certificate for brucellosis-free going sanitation in order to obtain a brucellosis- rearing establishment is valid for 12 (twelve) 136 free certificate must comply with the following months. measures: Art. 59. Renewal of the certificate for bru- I – to perform herd tests for the diagnosis of cellosis-free rearing establishment must be re- brucellosis leaving an interval of 30 to 90 days quested every year at the local official health between tests until a negative result is obtained, service unit, with negative results in the brucello- including the sanitary slaughter or sacrifice and sis diagnosis test performed on all animals speci- destruction of animals reacting positive as per fied on Article 20;; the provisions of Chapter IX; Art. 60. The accredited veterinarian must II – the sanitation period ends when 3 inform the local official health service unit of (three) consecutive negative herd test results are the date for blood sampling for the performance obtained, with an interval of 90 to 120 days be- of the tests mentioned on Article 59 at least 15 tween the first and second tests and of 180 to days in advance. 240 days between the second and third tests; Art. 61. Renewal of the certificate can be ex- III – animals reacting inconclusively to the tended for a maximum of 90 days if there is need brucellosis tests must be isolated from the herd to perform a further diagnosis test for brucellosis and retested 30 to 60 days after the previous on animals showing an inconclusive result in the test; annual retesting. IV – blood sampling for the third herd test, Art. 62. The detection of one or more animals reacting positive to a test performed by official health service veterinarian. The accred- an accredited veterinarian or official veterinar- ited veterinarian is responsible for informing the ian or after confirmation of clinical suspicions local official health and inspection service unit of will result in the temporary suspension of the the date of the test at least 15 days in advance. certificate for brucellosis-free rearing establishment. Returning to the free condition will re- CHAPTER XVIII quire 2 (two) negative herd tests performed with an interval of 30 to 90 days between them, the CERTIFICATION AS TUBERCULOSIS-FREE first performed 30 to 90 days after the sanitary REARING ESTABLISHMENTS slaughter or sacrifice and destruction of the last animal that reacted positive. Art. 64. The certificate for tuberculosis-free Sole Paragraph. The blood sampling in- rearing establishment will be issued by the Fed- tended for the second herd test to return to the eral Agriculture Agency, on condition that three free condition must be overseen by a state of- consecutive negative herd tests are obtained, ficial health and inspection service veterinarian performed within an interval of 90 to 120 days and the tests must be performed at an accred- between the first and second tests and of 180 to ited official laboratory. The accredited veterinar- 240 days between the second and third tests. ian must inform the local official health an in- Art. 65. The certificate for tuberculosis-free spection service unit of the blood sampling date rearing establishment is valid for 12 (twelve) at least 15 days in advance. months. Art. 66. Renewal of the certificate for tu- CHAPTER XVII berculosis-free rearing establishment must be requested every year at the local official health SANITATION FOR CERTIFICATION AS and inspection service unit, with negative results TUBERCULOSIS-FREE REARING in the tuberculosis diagnosis test performed on ESTABLISHMENT all animals aged six weeks and up.. Art. 67. The accredited veterinarian must Art. 63. Any rearing establishments undergo- inform the local official health service unit of ing sanitation to obtain a tuberculosis-free certifi- the date when the tests mentioned on ARTICLE cate must comply with the following measures: 66 are to be performed at least 15 days in ad- 137 I – to perform herd tests for tuberculosis on vance. the animals specified in Article 28, leaving an Art. 68. Renewal of the certificate can be interval of 90 to 120 days between tests, until extended for a maximum of 90 days if there is one negative herd test is obtained. Any animals need to perform a further diagnosis test for tu- reacting positive must be sent to sanitary slaugh- berculosis on animals showing an inconclusive ter or sacrifice and destruction, according to the result in the annual retesting. provisions of Chapter IX; Art. 69. The detection of one or more ani- II – the sanitation period ends when three mals reacting positive to the test performed by consecutive negative herd tests are obtained, an accredited veterinarian or an official veteri- with an interval of 90 to 120 days between the narian, or following confirmation of clinical sus- first and second tests and of 180 to 240 days be- picions, will result in the temporary suspension tween the second and third tests; of the certificate for tuberculosis-free rearing es- III – animals showing inconclusive reactions tablishment. In order to return to the free condi- to the diagnosis test for tuberculosis must be iso- tion, it will be necessary to obtain two negative lated from the herd and retested 60 to 90 days herd tests performed at an interval of 90 to 120 after the previous test; days. The first test is to be performed 90 to 120 IV – performance of the third herd test spec- days after the sanitary slaughter or sacrifice and ified in numeral II must be overseen by the state destruction of the last positive reacting animal. Sole Paragraph. The second herd test per- from the local official health and inspection ser- formed in order to return to a free condition vice unit with which the rearing establishment must be overseen by a state official health and is registered. inspection service veterinarian. The accredited Art. 73. The rearing establishment moni- veterinarian must inform the local official health tored for brucellosis and tuberculosis is hereby service unit of the date when the test is to be under obligation to: performed at least 15 days in advance. I – comply with measures to control and Art. 70. The detection of suggestive le- eradicate brucellosis and tuberculosis, as pro- sions of tuberculosis during the postmortem vided for in this Regulation; sanitary inspection of animals from tubercu- II – operate under the technical supervision losis-free rearing establishments implies on of an accredited veterinarian; sending samples of the suspicious lesions to III – use an individual identification sys- the laboratory indicated by the Animal Health tem for females aged 24 months and up, as and Inspection Department. If infection by well as bulls, as indicated by the Ministry of Mycobacterium bovis is confirmed, all animals Agriculture, Livestock and Food Supply or, if aged six weeks and up must be submitted to there is no indication by the Ministry, to use the tuberculosis test, and animals reacting their own animal identification system as long positive shall be sent to sanitary slaughter or as it is approved by the official health and in- sacrifice and destruction as per the provisions spection service; of Article 69. IV – vaccinate all females between three and eight months of age against brucellosis, us- CHAPTER XIX ing the B19 vaccine; V – submit females aged 24 months and up, CERTIFICATION OF REARING as well as bull, to tests for the diagnosis of bru- ESTABLISHMENT MONITORED FOR cellosis and tuberculosis, to which any animals BRUCELLOSIS AND TUBERCULOSIS reacting positive shall be sent to sanitary slaughter or sacrifice and destruction, according to the Art. 71. The certification of rearing estab- provisions of Chapter IX; lishment monitored for brucellosis and tubercu- VI – bear the costs of activities to control losis shall be issued by the Federal Agriculture brucellosis and tuberculosis. 138 Agency. Art. 74. The first diagnosis test for brucello- Art. 72. The certification of rearing establish- sis and tuberculosis performed in the monitored ment monitored for brucellosis and tuberculosis rearing establishment will be performed by sam- must be adhered to voluntarily, and is restricted pling, according to Table 5. The animals will be to beef farms. It must be formally requested selected at random:

Table 5. Sampling table for the initial test in a monitored rearing establishment, according to the number of females aged 24 months and up, and of bulls in the establishment.

Existing animals Number to be tested (*) < 350 255 351 – 500 300 501 – 750 350 751 – 1500 400 1501 – 5000 440 > 5000 460 (*) Sampling parameters: (1) probability of detecting one or more reacting animals (degree of reliability) = 99%; (2) minimum expected percentage of reacting animals in herd = 1%.> Art. 75. After the first test by sampling as II – the diagnosis tests for tuberculosis must specified on Article 74, the rearing establishment be performed at an interval of 10 to 12 months, must keep a diagnosis routine, including periodic until two consecutive negative results are obtained retesting also by sampling, under the following for all animals tested, and the tests will then be conditions: performed at an interval of 18 to 24 months; I – the diagnosis tests for brucellosis must be III – periodic retesting will be performed ac- performed at an interval of 10 to 12 months; cording to Table 6:

Table 6. Sampling table for periodic retesting in a monitored rearing establishment, according to the number of females aged 24 months and up, and of bulls in the establishment.

Existing animals Number to be tested (*) < 350 200 351 – 500 225 501 – 750 250 751 – 1500 270 1501 – 5000 290 > 5000 300

(*) Sampling parameters: (1) probability of detecting of one or more reacting animals (degree of reliability) = 95%; (2) minimum expected percentage of reacting animals in herd = 1%.

Art. 76. In case of one or more animals as bulls not included in the initial sampling, in- whith positive reaction to the brucellosis tests cluding the sacrifice and destruction / sanitary during the sampling specified on Articles 74 and slaughter of all positives. 75; to another test performed under the respon- Art. 79. Renewal of the certificate for rear- sibility of a certified or official veterinarian; or ing establishments monitored for brucellosis following confirmation of clinical suspicions, all and tuberculosis shall be requested every year females aged 24 months and up, as well as all from the local official health and inspection 139 bulls not included in the initial sampling, will service unit, for which negative result must be have to be tested for the disease. presented for any diagnosis tests performed, and Art. 77. In case of one or more animals whith conditioned to the sanitary slaughter or sacrifice positive reaction to the tuberculosis tests during and destruction of all animals reacting positive the sampling specified on Articles 74 and 75; to for brucellosis and/or tuberculosis, according to another test performed by a certified or official the provisions of Chapter IX. veterinarian; or following confirmation of clinical Sole Paragraph. Renewal of the certificate suspicions, all females aged 24 months and up, can be extended for a maximum of 90 days if as well as all bulls not included in the initial sam- necessary to perform new diagnosis test for bru- pling, will have to be tested for the disease. cellosis or tuberculosis on animals presenting in- Art. 78. The certification as rearing estab- conclusive results in the annual retesting. An ex- lishments monitored for brucellosis and tuber- tension for the same period may be authorized culosis is valid for 12 months and will be issued if necessary in order to procede the sanitary after 100% of negative samples are obtained in slaughter or sacrifice and destruction of animals a test. If there are any positive animals, the cer- whith positive reactions. tificate may only be issued after examination of Art. 80. The accredited veterinarian must all females older than 24 months of age, as well inform the local official health and inspection service unit of the date when the tests men- mals must be kept isolated from the moment tioned in Article 79 will be performed at least 15 they enter the establishment until the second days in advance. negative result; Art. 81. The detection of suggestive lesions of c) the tests shall be performed by an accred- tuberculosis during the postmortem sanitary in- ited veterinarian spection of animals from rearing establishments Art. 83. The official veterinarian may at monitored for brucellosis and tuberculosis implies any moment and without burden to the owner, in sending samples of the suspicious lesions to the collect biologic material for brucellosis or tu- laboratory indicated by the Animal Health and In- berculosis tests, and oversee or perform diag- spection Department and, if an infection by My- nosis tests for tuberculosis with the objective of cobacterium bovis is confirmed, all females aged verifying and validating the sanitary condition 24 months and up, as well as all bulls, must be of the rearing establishment monitored for bru- subjected to diagnosis tests for tuberculosis. Any cellosis and tuberculosis. animals reacting positive shall be sent to sanitary slaughter or sacrifice and destruction, according CHAPTER XX to the provisions of Chapter IX. Art. 82. The entrance of females aged 24 CONTROL OF BOVINE AND months and up, as well as of bulls in rearing es- BUFFALO MOVEMENT tablishments monitored for brucellosis and tuberculosis is conditioned to: Art. 84. For the purposes of interstate move- I – their being from a brucellosis-free rearing ment of male and female cattle and buffalo for establishment or from a rearing establishment reproduction, the presentation of negative re- monitored for brucellosis and tuberculosis, or af- sults to brucellosis and tuberculosis tests is man- ter undergoing two diagnosis tests for brucello- datory, and the following must be obeyed: sis, complying with the following requirements: I – issuing the Animal Movement Permit a) both tests must have a negative result; (GTA) is conditioned to the presentation of nega- b) the first test must be performed within a tive certificates for brucellosis and tuberculosis, 30 day period prior to loading, and the second issued by a accredited veterinarian or, until July test within 30 days after entering the rearing es- 31, 2005 (changed by Normative Instruction No. tablishment of destination, with a minimum in- 59 of august 24, 2004), by a registered veterinar- 140 terval of 30 days between tests, and the animals ian. The certificates must be attached to the copy must be kept isolated from entering the estab- of the GTA travelling with the animals; lishment until the second negative result; II – the diagnosis tests must have been per- c) the tests will be performed by a accredited formed by an accredited veterinarian, an accred- veterinarian, accredited laboratory or accredited ited laboratory, an accredited official laboratory official laboratory. or, until July 31, 2005 (changed by Normative II – their being from a tuberculosis-free Instruction No. 59 of august 24, 2004), by a regis- rearing establishment or from a rearing estab- tered veterinarian; lishment monitored for brucellosis and tuber- III – negative certificates for brucellosis and culosis, or after undergoing two diagnosis tests tuberculosis shall be valid for 60 (sixty) days, for tuberculosis, complying with the following counted from the date the blood samples were requirements: collected for the brucellosis test, and the date a) both tests must have a negative result; the tuberculosis test was performed; b) the first test must be performed within IV – diagnosis tests for brucellosis are a 30 day period prior to loading, and the sec- mandatory for the animals specified on Ar- ond test within 90 days of entering the rearing ticle 20, except for animals from rearing es- establishment of destination, with a minimum tablishment certified as brucellosis-free, or interval of 60 days between tests, and the ani- from rearing establishment monitored for brucellosis and tuberculosis; females up to 24 months of age – as long as they V – diagnosis tests for tuberculosis are have been vaccinated between three and eight mandatory for animals aged six weeks and up, months of age –, castrated animals and animals except for animals from a rearing establishment from brucellosis-free rearing establishments are certified as tuberculosis-free, or from a rearing hereby excluded from the tests; establishment monitored for brucellosis and c) proof of vaccination against brucellosis in tuberculosis. the rearing establishment of origin. Sole Paragraph. Starting on a date to be II – for tuberculosis: determined by the Animal Health and Inspec- a) certificate bearing a negative result to the tion Department, the interstate movement of diagnosis test for tuberculosis, performed within a cattle and buffalo for reproduction will only be 60 day period before the beginning of the event, allowed for animals from rearing establishments for animals aged six weeks and up, issued by a certified as brucellosis- and tuberculosis-free, or accredited veterinarian or, until July 31, 2005 from rearing establishments monitored for bru- (changed by Normative Instruction No. 59 of au- cellosis and tuberculosis. gust 24, 2004), by a registered veterinarian; Art. 85. Issuing the GTA for the movement b) animals being sent for sanitary slaughter of cattle and buffalo for any purpose is condi- and animals from tuberculosis-free establish- tioned to proof of vaccination against brucellosis ments are hereby excluded from the provisions in the rearing establishment of origin, according of the item above. to the provisions of Chapter III. Art. 88. Animals headed for participation at Art. 86. The international movement of auctions are exempt from presenting negative animals, semen and embryos is ruled by the certificates, except when deemed necessary by standards provided for in the International Ani- the state official service. mal Health Code of the World Organization for Art. 89. Starting on a date to be determined Animal Health (OIE), or according to standards by the Animal Health and Inspection Depart- specified in international agreements. ment, the issuing of GTA for the participation of cattle and buffalos in exhibitions, fairs and CHAPTER XXI at registered animal auctions is conditioned to their being from brucellosis- and tuberculosis- PARTICIPATION IN EXHIBITIONS, free rearing establishment. 141 FAIRS, AUCTIONS AND OTHER ANIMAL AGGLOMERATIONS CHAPTER XXII

Art. 87. Issuing an Animal Movement Per- ROLE OF THE OFFICIAL mit (GTA) for cattle and buffalo for participation INSPECTION SERVICE in exhibitions, fairs, auctions and other animal agglomerations is conditioned to the observance Art. 90. The official inspection service takes of the following requirements: part in the National Program for the Control and I – for brucellosis: Eradication of Animal Brucellosis and Tubercu- a) certificate bearing a negative result to a losis in collaboration with the official health and diagnosis test for brucellosis performed within inspection service with the purpose of improving a 60 day period before the beginning of the the efficiency of the sanitary surveillance and event, for animals over eight months of age, monitoring actions of this Program. issued by a accredited veterinarian or, until Art. 91. The following duties are specific to July 31, 2005 (changed by Normative Instruc- the official inspection service: tion No. 59 of august 24, 2004), by a registered I – to perform the sanitary slaughter of ani- veterinarian; mals identified as positive for brucellosis or tu- b) animals being sent for sanitary slaughter, berculosis; II – to comply with hygienic-sanitary proce- III – to communicate the official health dures and to judge and give destination to the and inspection service of any suggestive find- carcasses and viscera, according to the provi- ings of tuberculosis on carcasses and viscera sions of the pertinent legislation; at slaughter.

SERVICE INSTRUCTION DDA No. 6 OF MARCH 27, 2003

Establishes criteria for recognition of Training Courses on Animal Brucellosis and Tuberculosis Diagnostic and Control Methods and on Notions of Transmissible Spongiform Encephalopathies (TSEs) for accreditation of veterinary doctors under the National Program on the Control and Eradication of Animal Brucellosis and Tuberculosis-PNCEBT.

The Ministry of Agriculture, Livestock, and tural Superintendence in the respective state, as Food Supply’s Animal Health and Inspection well as meeting the following requirements: Department, by virtue of the powers vested in I. Have on its staff at least two veterinary it under Art. 18 of Ministerial Ruling No. 574 of doctors qualified by the Ministry of Agriculture, December 8, 1998: Livestock, and Food Supply, who have a record Whereas the Technical Regulations of the of 100-percent attendance at a seminar on the National Program for the Control and Eradication PNCEBT; of Animal Brucellosis and Tuberculosis have been II. Have on its staff or hire a veterinary doc- approved under SDA Normative Instruction No. 2 tor with experience in pathology, duly qualified of January 10, 2001; by the Ministry of Agriculture, Livestock, and Whereas there is a need to standardize the Food Supply, who has a record of 100-percent at- criteria for accreditation of training courses on tendance at a seminar on notions of TSEs; methods of animal brucellosis and tuberculosis III. Have equipment and facilities for the diagnostic and control for the accreditation of teaching of theoretical classes sufficient to ac- veterinary doctors as well as the need to enhance commodate up to twenty students per course; surveillance of transmissible spongiform enceph- IV. Have equipment and laboratory facilities 142 olopathies (TSEs), as described in Annex II hereto; RESOLVES: V. Ensure conditions to allow each partici- 1. Training courses on methods of diagnostic pating veterinary doctor to test at least twenty and control of animal brucellosis and tuberculosis serums for brucellosis – ten with positive and ten and on notions of TSEs aimed at veterinary doc- with negative results; and tors shall be offered by educational institutions VI. Have available for each course at least accredited by the Ministry of Education (MEC), or twenty bovines in good physical and sanitary by veterinary medicine research institutions. condition. 2. Any educational or veterinary medicine re- Of these animals, eight must be sensitized search institution interested in offering the afore- by the inoculation of 10 mg of Mycobacterium mentioned course must submit an application by bovis, AN5 sample, and two by the inoculation of filling out the form shown in Annex I hereto to 10 mg of Mycobacterium avium, D4 sample. The the Animal Health Service of the Federal Agricul- remaining ten should not be sensitized COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING DDA No. 73 OF DECEMBER 4, 2003

Published in the Official Gazette of December 8, 2003 Section 2, Page 4

Establishes the structure of the Consultative Scientific Committee on Animal Brucellosis (B. abortus) and Tuberculosis (M. bovis)-CCBT under the National Program for the Control and Eradication of Animal Brucellosis and Tuberculosis (PNCEBT), and specifies the area ascribed to each of its members.

ADMINISTRATIVE RULING No. 10 OF MARCH 7, 2003

Published in the Official Gazette of March 11, 2003 Section 1, Page 8

Establishes the Consultative Scientific Committee on Animal Brucellosis (B. abortus) and Tuberculosis (M. bovis)-CCBT.

ADMINISTRATIVE RULING No. 64 OF MARCH 18, 2003

Published in the Official Gazette of March 23, 2003 Section 1, 4198

Approves the Instructions annexed to this Administrative Ruling, regarding the Tuberculin Norms of Production, Control and Application. 143 NORMATIVE INSTRUCTION No. 59 OF AUGUST 24, 2004

Published in the Official Gazette of August 28, 2004 Section 1, Page 9 Modifies Normative Instruction No. 6 of January 8, 2004

Extends from July 31, 2004 to July 31, 2005 the deadline set under Art. 18, paragraph 2, Art. 21, item I; Art. 27, paragraph. 2; Art. 28; Art. 84, II and II; and Art. 87, I, a and II, a, respectively under Chapters V, VI, VI, VII, VIII, XX and XXI of the Technical Regulations of the National Program for the Control and Eradication of Animal Brucellosis and Tuberculosis, approved under SDA Normative Instruction No. 6 of January 8, 2004.

NORMATIVE INSTRUCTION No. 15 OF FEBRUARY 19, 2004

Published in the Official Gazette of February 25, 2004 Section 1, Page 2

Approves the Technical Regulations for the quality control and production of vaccines against brucellosis, and antigens for brucellosis diagnosis. SERVICE INSTRUCTION SDA No. 19 OF JUNE 28, 2002

Provides for the distribution of antigens and tuberculin for the diagnostic of brucellosis and tuberculosis.

SERVICE INSTRUCTION DDA No. 21 OF DECEMBER 7, 2001

Provides for the marketing and use of the brucellosis vaccine.

NATIONAL HERBIVORE RABIES CONTROL PROGRAM

ADMINISTRATIVE RULING SDA No. 168 of September 27, 2005

Published in the Official Gazette of September 29, 2005 Section 1, Page 9

Approves the Technical Manual for the Herbivorous Rabies Control – 2005 Edition.

THE MINISTRY OF AGRICULTURE, LIVESTOCK, CONTROL, 2005 Edition, prepared by this Office’s AND FOOD SUPPLY’S ANIMAL AND PLANT HEALTH Animal Health and Inspection Department for 144 AND INSPECTION SECRETARY, by virtue of the the use of public agents in actions under the Na- powers vested in him under Art. 42 of Annex I tional. Program on Herbivorous Rabies Control to Decree No. 5351 of January 21, 2005, having throughout the National Territory. in view the provisions under Normative Instruc- Art. 2. To determine the publication and tion No. 5 of March 1, 2002 and Proceeding No. wide publicizing of the Manual through the Min- 21000.004608/2005-04, istry of Agriculture, Livestock, and Food Supply’s RESOLVES: website. Art. 1. To approve the hereto annexed Art. 3. This Administrative Ruling shall enter TECHNICAL MANUAL ON HERBIVOROUS RABIES into force on the day of its publication.

GABRIEL ALVES MACIEL NORMATIVE INSTRUCTION No. 5 OF MARCH 1, 2002

Published in the Official Gazette of March 04, 2002 Section 1, Page3

Approves the Technical Norms for the Control of Rabies in Domestic Herbivores

THE STATE MINISTER OF AGRICULTURE, LIVE- Ruling No. 516 of December 9, 1997, will be in STOCK AND FOOD SUPPLY, exercising the powers effect with the following wording: conferred upon him by art. 87, sole paragraph of b) the incorporation of bovine spongiform the Constitution, taking into account the provi- encephalopathy, scrapie and other diseases with sions of art. 86, of the Statute of the Animal Health neurological progressive symptomology to the and Inspection Department, approved by Decree surveillance system of rabies in domestic herbiv- no. 24 548, July 3, 1934, and which is reported in orous animals in the manner to be established the Process no 21000.009298/2001-82, decides: in an act of the Ministry of Agriculture, Livestock Art. 1. To approve the Technical Norms for and Food Supply. the control of rabies in domestic herbivorous Art. 3. This Normative Instruction will be in animals, according to the Annex of this Norma- effect as of the day of its publication. tive Instruction. Art. 4. The Administrative Ruling no. 126 of Art. 2. Item “b” of art. 3 of Administrative March 18, 1976 is hereby revoked.

MARCUS VINICIUS PRATINI DE MORAES

ANNEX

TECHNICAL NORMS FOR THE CONTROL OF RABIES IN DOMESTIC HERBIVOROUS ANIMALS 145 CHAPTER I through preventive immunization, according to policy recommended by the World Health Orga- PRELIMINARY PROVISIONS nization.

Art. 1. For the purpose of these Rules, an CHAPTER II owner shall be he who is holder, depositary or in any way keeps animals susceptible to rabies. PROGRAM OBJECTIVE AND OPERATION Art. 2. The owner shall promptly warn the STRATEGY Official Veterinary Service of any incident or sus- Art. 5. The National Program for the Rabies picion of rabies, as well as the presence of ani- Control in Herbivorous Animals is meant to lower mals attacked by hematophagous bats or the ex- the prevalence of the disease in domestic her- istence of shelters of such species. bivorous population. Art. 3. The Official Veterinary Service should Art. 6. Program operation strategy is based take the necessary steps to assist the animals and on the vaccination of domestic herbivorous ani- collect material for rabies and other differential mals, control of sources of rabies infection and encephalitis diagnosis. other animal health and inspection procedures Art. 4. The officials working in laboratory to protect public health and develop of bases of or in disease control activities must be protected future actions to control this disease. CHAPTER III rabies vaccine should be stocked at two to eight centigrade degrees. VACCINATION Art. 14. Whenever required by the Veteri- nary Official Service, the institution responsible Art. 7. For prophilaxis of rabies in herbivo- for selling the vaccine is obliged to communicate rous animals, an inactive vaccine will be used, in the purchase, selling and supply of vaccine. a two (2) ml doses, will be administered by the Art. 15. Whenever needed, the anti-rabies owner, through subcutaneous or intramuscular vaccines produced in Brazil or imported will be application. collected for fiscal inspection wherever they are Art. 8. In areas with rabies events, the vac- to assess their effectiveness. cination will be systematically adopted for cattle and equidae at or above three (3) months of age, CHAPTER V under the supervision of the veterinary. Paragraph 1. Vaccination of cattle and equi- CONTROL OF SOURCES OF dae under three (3) months of age and other spe- RABIES INFECTION cies can be done at veterinary’s discretion. Paragraph 2. Animals being vaccinated Art. 16. Teams working in rabies outbreaks for the first time should be revaccinated after should carry out inquiries to determine the pres- thirty (30) days. ence of other species other than bats that could Art. 9. The anti-rabies vaccine certificate function as sources of rabies infection. will be issued by the veterinary, and will be valid Art. 17. The chosen method to control the through the protection period of the vaccine ap- sources of rabies infection will depend on the ani- plied. mal species, on the topography of the area and on Sole paragraph. In order to complement possible legal restrictions. vaccination confirmation, animal owners may be Art. 18. Until studies are accomplished re- asked for: garding other products, the method to control I - receipt of vaccine acquisition, which hematophagous bats will be based on the use of should include departure number, validity and anticoagulant substances. producing laboratory; Art. 19. The application of anticoagulant sub- II - vaccination date notation, number of stances in hematophagous bats should be carried 146 vaccinated animals by species and their respec- out under the supervision of the veterinary. tive identification. Art. 20. The application of anticoagulant sub- Art. 10. The duration of the vaccine immu- stances around recent lesions by hematophagous nity for herbivorous animals, for revaccination bats in herbivorous animals should be done by the purposes, will be twelve (12) months at most. producer, under the orientation of the veterinary. Art. 21. Anticoagulant substances and “ny- CHAPTER IV lon” nets used to control hematophagous bats are program exclusive-use materials. VACCINE PRODUCTION, CONTROL Art. 22. In refuges, the use of other methods AND SALE to control hematophagous bats is recommended, provided the places are easy to access and present Art. 11. Production and control of all vaccine good working conditions, at veterinary’s discretion. allotments will comply with all rules of the Ani- Art. 23. The refuges of hematophagous bats, mal Health and Inspection Department, where all especially those of the species Desmodus rotun- the vaccines should be previously licensed. dus, notified to the Official Veterinary Service, Art. 12. Solely vaccine with expiration date should be registered and revised periodically, in greater or equal to one (1) year will be approved. order to maintain the control of the existing bat Art. 13. From production to its use, anti- population in the refuges. Art. 24. When rabies occur in wild carnivo- and done by a veterinary or an assistant with ap- rous, an epidemiological survey should be carried propriate training and properly immunized. out, in order to verify the origin of the case and, if Art. 33. Samples of the central nervous sys- there is an outbreak reaching one or more species, tem of the animal suspicious of having rabies the control of that population will be promoted, should be collected after its death, or when the through systematic captures, to determine viral animal is sanitary slaughtered in the early phase activity and the extension of the outbreak. of the disease (paralytic phase). Art. 34. Samples of the central nervous sys- CHAPTER VI tem of the suspicious animal should be sent to the laboratory, as well as ten percent (10%) of the OTHER MEASURES OF captured hematophagous bats. EPIDEMIOLOGICAL SURVEILLANCE Art. 35. The exams of the collected material will be processed through the direct immunofluo- Art. 25. In the epidemiological surveillance rescence technique and biological proof (inocula- of the disease, an information system will be es- tion in mice or cells), or other technique recom- tablished, which will include the obligatory notifi- mended by the World Health Organization, in a cation of cases and continuous information. private or official laboratory, accredited by the Art. 26. Permanent diagnosis of the epide- Ministry of the Agriculture, Livestock and Food miological situation will be made, as well as the Supply – MAPA. analysis of the conditioning factors, and rabies magnitude, distribution and propagation. CHAPTER VIII Art. 27. All areas where the disease has been confirmed in the past two (2) years will be consid- SANITARY EDUCATION AND PROMOTION ered rabies occurrence areas. Art. 28. Control zone or area shall be consid- Art. 36. All available means and information, ered all areas where rabies control reached satis- political, ecclesiastical and education representa- factory levels, with the cattle and equidae properly tives should be used for sanitary education and vaccinated and transmitter population reduced. promotion in order to reach as many breeders Art. 29. Immediate operation area shall be all and other members of the rural community as areas where an endemic state of rabies is found, possible. 147 as well as where there are requests for prompt in- Art. 37. The organization of all different so- tervention. cial actors of the community in Municipal or Inter- Art. 30. Focal and perifocal vaccinations will municipal Animal Sanity Councils, integrated with include all existing properties in the infected area, a State Animal Sanity Council, is fundamental to covering a radius of up to twelve (12) km; the effectively solve the problem of rabies in domestic combat of transmitters shall proceed likewise. herbivorous animals. Art. 31. The surveillance of transmitters should be constantly maintained through the CHAPTER IX verification of bite coefficient and their population dynamics. GENERAL PROVISIONS

CHAPTER VII Art. 38. Technical and auxiliary personnel in charge of controlling rabies must be MATERIAL COLLECTION provided continuous specialized training on AND LABORATORY EXAMS vaccine control, epidemiology, statistics, planning and management of sanitary campaigns, Art. 32. The collection of material of animals laboratory diagnosis, bioecology and control suspicious of suffering from rabies will be guided of hematophagous bats, handling of non-hematophagous bats and sanitary education. vine spongiform encephalopathy, scrapie and Art. 39. The rabies combat activities will other diseases that present nervous symptom- have a national character and all states should ology of progressive character to the surveil- create specific laws based on current Norms. lance system of rabies in domestic herbivorous Art. 40. Laboratories that produce vaccines animals. will have one-hundred eighty (180) days, after Art. 42. The Animal and Plant Health an In- the publication of this Normative Instruction, to spection Secretariat - SDA, of the Ministry of Ag- make all necessary changes in order to fully com- riculture, Livestock and Food Supply, will create ply with it. complementary instructions on the matter and Art. 41. Incorporate the surveillance of bo- solve the cases omitted.

COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING No. 34 OF MAY 28, 2004

Published in the Official Gazette of June 1, 2004 Section 2, Page 4

Establishes the makeup of the Consultative Scientific Committee on Herbivorous Rabies- CCR.

ADMINISTRATIVE RULING SDA No. 8 OF JANUARY 31, 2003

Published in the Official Gazette of February 3, 2003 Section 1, Page 5

Sets up the Consultative Scientific Committee on Rabies-CCR. 148

NORMATIVE INSTRUCTION SDA No. 69 OF DECEMBER 13, 2002

Published in the Official Gazette of December 16, 2002 Section 1, Page 29

Determines the use of a seal of guarantee (holographic) on all vials of vaccine against herbivorous rabies in lots approved and released by the Ministry of Agriculture, Livestock, and Food Supply for marketing, so as to ensure conformity with the norms on control of the production and marketing of vaccines against herbivorous rabies. NATIONAL PROGRAM FOR THE PREVENTION AND CONTROL OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADMINISTRATIVE RULING No. 516 OF DECEMBER 9, 1997

Published in the Official Gazette of December 1, 1997 Section 1, Page 29476

Modified by the Normative Instruction No. 5 of March 1, 2002 Declares Brazil free of bovine spongiform encephalopathy pursuant to Art. 3.2.13.2 of the International zoosanitary Code.

THE MINISTER OF AGRICULTURE, LIVESTOCK thy and other animal transmissible spongiform AND FOOD SUPPLY, using the assignments given encephalopathies, reported on article 3.2.13.1 by the Article 87, Sole Paragraph, part II, of the of the International Animal Health Code, espe- Constitution of the Republic, considering what cially: has been determined on Article 71 of the Animal a) the identification of potential danger of Sanitary Health an Inspection Service Regulation, disease introduction through risk analysis that in- approved by the Decree number 24.548, of July 3, clude the importation of alive animals, products 1934, considering the decision of the 65th Gener- and byproducts of animal origin; al Meeting of the World Organization for Animal b) the annexation of bovine spongiform Health - OIE, which altered chapter 3.2.13 - Bo- encephalopathy, scrapie and other progressive vine Spongiform Encephalopathy, of the Interna- nervous signs diseases in the domestic herbivore tional Animal Health Code, resolves to: rabies surveillance system, being established by Art. 1. Declare Brazil free from Bovine an Act of the Ministry of Agriculture, Livestock Spongiform Encephalopathy, according to what and Food Supply. article 3.2.13.2 of the International Animal c) the prohibition of using any source of ru- 149 Health Code established. minant protein in the feeding of the same, ex- Art. 2. Include Bovine Spongiform Encephal- cept for dairy proteins. opathy and scrapie in the list of diseases subject Art. 4. Delegate the competence to the Ani- to animal sanitary health measures reported on mal and Plant Health and Inspection Secretariat article 61 of the Animal Sanitary Health Service of lowering the necessary complementary regu- Regulation, approved by Decree number 24.548, lations to the implementation of what has been July 3, 1934. disposed in this Administrative Ruling. Sole Paragraph - Bovine spongiform en- Art. 5. The entry in Brazil of animals and cephalopathy and scrapie are diseases of com- products and byproducts of animal origin from pulsory notification and their occurrences or third part countries is conditioned to proof of suspicions shall be immediately reported to the following the surveillance measures of transmis- jurisdiction’s animal sanitary health and inspec- sible spongiform encephalopathies and that are tion authority. recommended on Chapter 3.2.13 of the Interna- Art. 3. Determine the application, from tional Animal Health Code. January 1 , 1998, of the recommendations for Art. 6. This Administrative Ruling will be in prevention of bovine spongiform encephalopa- force with effect from the date of its publication.

MARCUS VINICIUS PRATINI DE MORAES NORMATIVE INSTRUCTION No. 49 of September 15, 2008

Published in the Official Gazette of September 16, 2008 Section 1, Page8

Establishes the following categories of risk for Bovine Spongiform Encephalopathy – BSE: Category I – countries with negligible risk of BSE; Category II – countries with controlled risk of BSE; Category III – countries with an undetermined or unclassified risk of BSE.

THE MINISTRY OF AGRICULTURE, LIVESTOCK and ingredients of animal origin destined for ani- AND FOOD SUPPLY , through the jurisdiction con- mal feeding in cases where the animal originates ferred to it by Article 87(2) of the Constitution, or come from countries in Categories I or II. taking into consideration that contained in De- Art. 5. To exclude from prohibitions men- cree No.5,741 of March 30, 2006; in Article 71 of tioned in Articles 3 and 4 of this Normative In- Decree No. 24,548 of July 3, 1934; in Articles 1 struction, in compliance with sanitary requisites and 2 of Law No. 6,198 of December 26, 1974 and stipulated by MAPA, the following products: milk Process No. 21000.001378/2008-66 resolves: and dairy products; semen and embryos from Art. 1. To establish the following categories cattle reared conforming to guidelines set out by of risk for Bovine Spongiform Encephalopathy the International Embryo Transfer Society; depro- (BSE): Category I – countries with negligible risk teinised animal fats and their derivatives (with in- of BSE; Category II – countries with controlled soluble impurities corresponding to a maximum risk of BSE; Category III – countries with an unde- of 0.15% of the weight); leathers and skins; and termined or unclassified risk of BSE. gelatine and collagen processed in accordance Sole Paragraph. The classification of coun- with the OIE’s Terrestrial Animal Health Code. tries in this article will follow the World Organi- Sole Paragraph. Following review and con- sation for Animal Health (OIE) own classification sideration in accordance with SDA criteria, other based on the sanitary situations of member products and inputs may be included in the list countries with respect to BSE. outlined by this Article. Art. 2. All countries which have been noti- Art. 6. To approve the “Decision matrix for the fied indigenous cases of BSE or are classified as importation of animals, products and subprod- 150 category III are considered as BSE risk for sanitary ucts of animal origin, taking into consideration slaughter reasons. the risk for Bovine Spongiform Encephalopathy Art. 3. To prohibit the importation of rumi- (BSE)” as detailed in this Normative Instruction. nants, their products and subproducts irrespec- Sole Paragraph. This decision matrix should tive of purpose; of products intended for veteri- be used to analyse the importation of animals, nary use containing ingredients of ruminant ori- their products and subproducts of animal origin. gin; and of products and ingredients of animal Art. 7. The complementary acts necessary for origin destined for the alimentation of animals in the application of this Normative Instruction will cases where the animal originates or come from be elaborated and published by the Animal and countries classified in Category III. Plant Health and Inspection Secretariat (SDA). Art. 4. To subject to the compliance of sani- Art. 8. Doubts and omissions will be resolved tary requisites established by Animal and Plant by MAPA. Health and Inspection Secretariat (SDA), the im- Art. 9. This Normative Instruction will enter portation of ruminants, their products and sub- in vigour 60 (sixty) days after the date of its pub- products irrespective of purpose; of products lication. intended for veterinary use containing principle Art. 10. Ministerial Normative Instruction ingredients of ruminant origin; and of products No. 7 of March 17, 2004 is hereby revoked. REINHOLD STEPHANES ANNEX

Decision Matrix to be used in considering the risk for Bovine Spongirm Encephalopathy (BSE) for the importation of animals, animal products and subproducts of animal origin

Risk Product Risk Country

I II III I R R P II A R P III A A R

References: ing principle ingredients of ruminant origin • Decision: with the exception of those products listed in - P: Importation prohibited. Category III; - R: Importation subject to restriction and control - Readymade animal feeds composed of prod- of product integrity in accordance with sanitary ucts and ingredients derived from ruminants, exigencies stipulated by MAPA. with the exception of those composed exclusively - A: Importation authorised in accordance with products listed in Category III. sanitary exigencies stipulated by MAPA. Category II: • Country Risk: - Products and byproducts of non-ruminant ori- - Category I: Countries at negligible risk of BSE. gin destined for animal feeding, with the excep- - Category II: Countries with controlled risk of tion of those composed exclusively of products BSE. listed in Category III. - Category III: Countries with an undetermined or - Readymade animal feeds composed of products unknown risk of BSE. and ingredients of animal origin, except those derived from ruminants. • Product Risk: - Principle ingredients derived from ruminants 151 The categories of product risk were stipulated for use in laboratories; based upon available scientific information and - Material containing principle ingredients de- the World Organisation for Animal Health (OIE) rived from ruminants for use in scientific and Terrestrial Animal Health Code. technological research with diverse use in vitro; In order to grade a product’s risk of BSE, consider - Residues of the rearing or slaughter of pigs Category I as highest risk, Category II as iinter- and birds. midiate risk and Category III as least risk: Category III Category I: - Products included in Article 5 of this Normative - Live ruminants; Instruction. - Products and subproducts of ruminants, includ- - Kits for diagnostic tests in vitro developed with ing those used in animal feed, with the exception principle ingredients derived from ruminants; of those composed exclusively of products listed - Material containing principle ingredients derived in Category III; from ruminants for use in scientific and techno- - Products intended for veterinary use contain- logical research with exclusive in vitro use. NORMATIVE INSTRUCTION No. 15 OF APRIL 2, 2008

Published in the Official Gazette of April 4, 2008 Section 1, Page 2

Approves the Procedures for Action in Suspected Cases of Scrapie.

THE MINISTER OF AGRICULTURE, LIVESTOCK, RESOLVES: AND FOOD SUPPLY, by virtue of the powers vested Art. 1. To approve the Procedures for Action in him under Art. 87, sole para., II of the Constitu- in Suspected Cases of Scrapie, the Disclaimer, and tion, and having in view Decree No. 5741 of March the Epidemiologic Investigation Questionnaire – 30, 2006; Decree No. 24548 of July 3, 1934; Ad- Annexes I, II, and III hereto, respectively. ministrative Ruling No 516 of December 9, 1997; Art. 2. This Normative Instruction shall enter and Proceeding No. 21000.014191/2006-61, into force on the day of its publication.

REINHOLD STEPHANES

ANNEX I

PROCEDURES FOR ACTION IN SUSPECTED CASES OF SCRAPIE

CHAPTER I is the one that persists after clinical, epidemiological, and differential investigation of other OBJECTIVES AND diseases, such as scabies and other ectoparasites, GENERAL DISPOSITIONS cenurosis, rabies, pseudorabies, ovine progressive pneumonia (Maedi-visna), encephalic listeriosis, 152 Art. 1. Establishment of Procedures for polioencephalomalacia, preeclampsia, photo- Action in Suspected Case of Scrapie in sheep sensitivity, hypomagnesaemia, and intoxication and goats by chemical substances or plants, among others. Art. 2. Scrapie is a fatal, transmissible neuro- Art. 5. Scrapie is diagnosed in sheep and degenerative disease that affects sheep and goats goats if they test positive in immunohistochemi- and that falls into the group of transmissible cal test of samples of nervous or lymphoid tissue spongiform encephalopathies-TSEs. or under other diagnostic techniques and meth- Art. 3. Scrapie is subject to mandatory no- odologies approved by the Ministry of Agricul- tification; suspected cases or occurrence must ture, Livestock, and Food Supply-MAPA. be promptly reported to the animal health and Sole Paragraph. Samples collected for inspection authorities at any level (Central and scrapie diagnostic should be sent to the TSE Superior, Intermediate, and Local Organs). diagnostic laboratories of the Agriculture and Art. 4. Sheep and goats aged more than 12 Livestock Health Care Unified System’s National (twelve) months are suspected if they show one Network of Agricultural and Livestock Labora- or more than one of the following nervous clini- tories, accompanied by the Standard Form for cal signs that persist for more than 15 (fifteen) Requesting Neurological Syndrome Analysis re- days: changed behavior, locomotion, or posture. ferred to in SDA Administrative Ruling No. 168, Sole Paragraph. A suspect case of scrapie of September 27, 2005. Art. 6. Owners or holders of sheep and samples should be collected from the third eyelid goats that are suspected of, at high risk for, or or another lymphoid tissue as necessary; and that have been exposed to scrapie are respon- 2. In the case of a dead suspected animal or sible for their custody and must sign the Dis- in case the owner chooses to procede the sacrifice claimer shown in Annex II of this Normative and destruction of the diseased animal, samples Instruction should be collected from nervous tissue, includ- Art. 7. A commission to evaluate the ani- ing the brain stem; lymphoid tissue, including mals that are the object of indemnification the third eyelid; and other tissues deemed neces- shall be appointed by the Ministry of Agricul- sary during necropsy. ture, Livestock, and Food Supply’s Federal Su- Art. 9. Suspected animals submitted to the perintendence in the respective State, pursuant lymphoid tissue test should remain under obser- to Law 569 of December d21, 1948. vation – and in isolation, in the case of females Sole Paragraph. No indemnification shall be – until the conclusion of lab results. granted for animals slaughetered and destroyed Art. 10. If laboratory results of tests done that may be the object of laboratory confirma- solely on lymphoid tissue are negative, the sus- tion of scrapie cases. pected animals should remain under observation – and in isolation, in the case of females – for CHAPTER II another 15 (fifteen) days. Paragraph 1. If there is no abatement of clin- ACTION IN CASES OF CLINICAL ical signs at the expiration of the aforementioned SUSPICION OF SCRAPIE deadline, suspected animals should be evaluated by the Evaluation Commission and sent to sani- Art. 8. In case of clinical suspicion of scrapie, tary slaughter and destruction for the collection the following measures shall be adopted by the of nervous tissue samples. Agriculture and Livestock Health Care Unified Sys- Paragraph 2. If clinical signs show abate- tem’s Intermediate or Local Organs: ment at the expiration of the aforementioned I – Visit to the establishment and substan- deadline, the establishment’s interdiction tiation of the suspicion based on the clinical should be promptly lifted and the suspicion and epidemiological investigation of the flock/ case closed pursuant to a complementary care herd; and form specified by the Animal Health Depart- 153 II – In case of a suspect case, the following ment-DSA/SDA/MAPA. actions should be undertaken: Art. 11. If laboratory tests on nervous tissue a) Interdiction of the establishment, which samples are negative, the establishment’s inter- consists in the prohibition of the entry and exit of diction should be promptly lifted, and the suspi- sheep and goats, as well as of products, byprod- cion case closed pursuant to the complementary ucts, and materials likely to be a scrapie trans- care form. mission or spreading means. Art. 12. In case technical conditions are b) Application of the Epidemiologic Investi- lacking for the collection of samples from a dead gation Questionnaire, pursuant to Annex III, of suspected animal, appropriate, auditable records this Normative Instruction; and about the care provided should be kept by the c) Collection of samples from suspected ani- competent Agriculture and Livestock Health Care mals and notification of the Agriculture and Live- Unified System’s Organ, and at the latter’s discre- stock Health Care Unified System’s Central and tion the establishment’s interdiction may be lift- Superior Organ responsible for the State where ed and the establishment may be placed under the suspicion occurs, by using the first care form routine surveillance. specified by the Animal Health Department-DSA/ Art. 13. The identification of the animals SDA/MAPA. referred to under Arts. 9 and 10 above shall be 1. In the case of a live suspected animal, incumbent on their owner or holder. Sole Paragraph. The individual identi- ters of a male tested positive for scrapie; and fication device shall be proposed by the Ag- other animals at the discretion of the Agricul- riculture and Livestock Health Care Unified ture and Livestock Health Care Unified System’s System’s Intermediate Organ and approved by competent Organ; the competent Federal Agricultural Superin- VI – Evaluation by the Evaluation Commis- tendence-SFA. sion, sanitary slaughter and destruction, and Art. 14. Dead suspected animals or ani- collection of samples from high-risk animals; mals sent to sanitary slaughter and destruction VII – Individual identification and isola- should be destroyed under the supervision of tion, at the discretion of the Agriculture and the Agriculture and Livestock Health Care Uni- Livestock Health Care Unified System’s com- fied System’s competent Organ. petent Organ, of exposed animals, i.e., all those that have had contact with matter ex- CHAPTER III pelled at birth, during parturition, or miscarriage of any animal tested positive for scrapie, ACTION IN THE pursuant to the establishment’s reproduction OCCURRENCE OF SCRAPIE management; VIII – Collection of lymphoid tissue samples Art. 15. Positive laboratory results shall from exposed animals aged over 12 (twelve) characterize an establishment as a Outbreak months; Property and the following measures shall Paragraph 1. At the owner’s or holder’s re- be adopted by the Agriculture and Livestock quest and at the discretion of Agriculture and Health Care Unified System’s Intermediate or Livestock Health Care Unified System’s compe- Local Organs: tent Organ, exposed animals under 12 (twelve) I – Interdiction of the establishment; months of age may be kept at the establish- II – Application of the Epidemiologic In- ment until they reach the age of 12 months, vestigation Questionnaire shown in Annex III when they should be subjected to the proce- hereto; dure referred to in the preceding Item VIII. III – Notification of the occurrence to the Paragraph 2. Exposed animals tested posi- Agriculture and Livestock Health Care Unified tive in the lymphoid tissue exam shall be sub- System’s Central and Superior Organ by the jected to the procedures described under item 154 State where the occurrence has taken place; IV above. IV – If positive animals are alive, they Paragraph 3. Exposed animals tested nega- should be sent to sanitary slaughter and de- tive in the lymphoid tissue exam shall be sub- struction : jected to surveillance by Agriculture and Live- a) The sanitary slaughter and destruction stock Health Care Unified System’s competent consists in the elimination of the animals, fol- Organ. lowed by destruction of the carcasses by in- Paragraph 4. The individual identification cineration, burial, or any other procedure ap- of animals referred to under items V and VI proved by MAPA, under the supervision of the above shall be incumbent on their owner or Agriculture and Livestock Health Care Unified holder with an identification device proposed System’s competent Organ at the raising estab- by the Agriculture and Livestock Health Care lishment or at another establishment designat- Unified System’s competent Organ and ap- ed by said Organ. proved by the competent Federal Agricultural V – Individual identification and isolation Superintendence. of high-risk animals, which are as follows: Art. 16. During interdiction, the exit of The grandmother, mother, and sisters and animals destined for sanitary slaughter shall female descendants of a female tested positive be permitted, provided said animals are not for scrapie; the grandmother, mother, and sis- being subjected to epidemiologic investigation as being positive, high-risk, or exposed. CHAPTER IV Sole Paragraph. The aforementioned sanitary slaughter shall be carried out at an EXPOSED ESTABLISHMENTS inspected establishment duly registered with the competent municipal, state, or federal Art. 18. Exposed establishments are those entity; carcasses may be used, while specific that have high-risk or exposed animals and risk materials (brain, spinal cord, eyes ton- that, should there be laboratory confirmation sils, spleen, and intestines from the duode- of scrapie, will be considered Outbreak Estab- num to the rectum) should be removed and lishments. destroyed. Paragraph 1. Exposed establishments shall Art. 17. Upon completion of the actions be interdicted and subjected to the Epidemio- referred to under Art. 15 above and at the logic Investigation Questionnaire pursuant to discretion of Agriculture and Livestock Health Annex III hereto;. Care Unified System’s competent Organ, the Paragraph 2. High-risk or exposed animals establishment’s interdiction may be lifted and found on exposed establishments shall be sub- the outbreak reported closed pursuant to the mitted to the procedures referred to under Art. complementary care form. 15, V-IX.

ANNEX II

DISCLAIMER

I hereby testify that I have under my responsibility sheep or goats considered as suspect, positive, or high-risk for scrapie. To prevent the disease from spreading, I commit myself not to sell said animals or transfer their ownership, and to notify the Agriculture and Livestock Health Care Unified System’s competent Organ of any change in their condition, such as:

- Disease; 155 - Death;

- Escape;

- Raiding or stealing.

I further testify that I am aware that full or partial noncompliance with the terms hereof shall entail sanctions under the legislation in force.

Owner: ______I.D. No.: ______

Establishment: ______Telephone ( ___) ______

Municipality: ______State: ______

Number of animals: ______(______).

Animals’ identification: Species Individual Name Gender Date of birth Breed identification (*)

(*) Approved by the Agriculture and Livestock Health Care Unified System’s competent Organ.

Place and date Owner’s signature

ANNEX III 156 EPIDEMIOLOGIC INVESTIGATION QUESTIONNAIRE

1. ESTABLISHMENT’S IDENTIFICATION 1. Name of owner or person in charge: 2. Name of establishment: 3. Geographic coordinates: 4. Name of primary/secondary shelter, if any: 5. Address: 6. Municipality: 7. State: 8. Mailing address: 9. Municipality: 10. State: 11. Postal Code (CEP): 12. Telephone Nos.: 13. E-mail: 2. ESTABLISHMENT’S MANAGEMENT DATA 14. Species: goats sheep 15. Breed(s): 16. Purpose: Subsistence Commercial

Meat Milk Meat Milk Meat and milk Cow calf Meat and milk Cow calf Rearing Fattening Rearing Fattening

F < 1 year: M < 1 year: F < 1 year: M < 1 year: 17. Number of animals: F > 1 year: M > 1 year: F > 1 year: M > 1 year: Total F: Total M: Total F: Total M: 18. Area (hectares): 19. Beginning of breeding operation: 20. Origin of first national:______(State) imported: ______(country) animals national:______(State) imported: ______(country)

21. Reproductive management of exposed species: a. Parturition stage: No Yes - Duration: days – Period of the year: b. Parturition location: Field Birthing corral Other: c. Duration of stay in parturition location: Pre-parturition: days – Post-parturition: days d. Placenta’s destination: None Burial Incineration Other:

3. IDENTIFICATION OF AFFECTED ANIMAL 157 22. Species: goat sheep 23. Breed: 24. Gender: M F 25. Date of birth or age: 26. Registration No.: 27. Tattoo/Earring: 4. DISEASE’S HISTORY 28. Date of first clinical signs: 29. Date of death: 30. Clinical signs: Self-mutilation Blindness Recumbency Motor incoordination Sideways head movement Behavioral change Vacant stare Wool or hair loss Marked weight loss Scratching Teeth grinding Nibbling reflex Slight tremor 31. Description of clinical signs, if necessary:

32. Veterinarian doctor responsible for clinical diagnostic: Name: CRMV No.:

5. TRACING OF AFFECTED ANIMALS

33. Born at the establishment? Yes No (indicate establishment, municipality, and State of origin):

34. Individual identification and list of high-risk kin animals on the establishment:

35. Individual identification and list of high-risk kin animals moved to other establishments and their destination:

36. Identification of exposed animals on the property: 158

37. Identification and destination of exposed animals moved to other properties:

Place and date:

Official veterinary doctor’s identification and signature: NORMATIVE INSTRUCTION No. 8 OF MARCH 25, 2004

Published in the Official Gazette of March 26, 2004 Section 1, Page 5

Forbids in the whole national territory the production, commercialization and use of products destined to the feeding of ruminants that contain in their composition proteins and fat of animal origin.

THE MINISTER OF AGRICULTURE, LIVESTOCK ed bone meal (without proteins and fat), and AND FOOD SUPPLY, using the assignments given gelatin and collagen prepared exclusively from by the Article 87, Sole Paragraph, part II, of the leather and skin are excluded from the prohibi- Constitution, considering what has been de- tion treated in the articles before. termined on Article 71 of the Animal Sanitary Sole Paragraph. According to the Animal Health Service Regulation, approved by the De- and Plant Health and Inspection Secretariat, cree number 24,548 of July 3, 1934, on articles based on risk analysis, other products and in- 1 and 2 of Law number 21000.008269/2003-65, put shall be excluded. and considering the epidemiology of Bovine Art. 4. Labels and tags of products des- Spongiform Encephalopathy – BSE and the ne- tined to non-ruminants feeding that contain cessity of maintaining the sanitary situation of any source of protein and fat of animal origin, Brazil related to this disease, resolves: except for those mentioned on Article 3 of this Art. 1. To forbid in the whole national ter- Regulation, shall contain on the main panel ritory the production, commercialization and and pointed out the following expression: “USE use of products destined to ruminants feeding FORBIDDEN IN RUMINANT FEEDING”. that contain in their composition proteins and Art. 5. Products destined to ruminant feed- fat of animal origin. ing are subjected to analysis examination to Sole Paragraph. This prohibition shall in- identify the ingredients used as protein source. clude the poultry litter, residues of pig rearing, Art. 6. The Animal and Plant Health and as well as any other product that contains pro- Inspection Secretariat and Secretariat for Rural 159 teins and fat of animal origin. Support and Co-operative Activities, in their Art. 2. The production, commercialization respective areas of competence, will dispatch and use of products, destined to ruminants, complementary instructions for the cases that used by veterinarians that contain in their for- need more regulation or for the default cases. mulation input from ruminants, is forbidden. Art. 7. This Normative Regulation will be in Art. 3. Milk and dairy products, calcinat- force with effect from the date of its publication.

ROBERTO RODRIGUES

(*) republished, due an inaccuracy compared to the original, in the Official Gazette of March 26, 2004, section 1, page 4. NORMATIVE INSTRUCTION NUMBER No. 7 OF MARCH 17, 2004

Published in the Official Gazette of March 18, 2004 Section 1, Page 3 Prohibits the importation of ruminants, their products and by-products intended to any means, and veterinary products that contain input from ruminants, when coming from countries that have registered domestic cases of BSE, or any other country considered as risk for the disease by the Animal and Plant Health and Inspection Secretariat

THE MINISTER OF AGRICULTURE, LIVESTOCK tended for ruminant feeding, and coming from AND SUPPLY, using the assignments given by the the same countries refered in the previous ar- Article 87, Sole Paragraph, part II, of the Constitu- ticle. tion, considering what has been determined on Art. 3. this prohibition exempts the follow- Article 71 of the Animal Sanitary Health Service ing products: milk and dairy products, semen Regulation, approved by the Decree number and embryos, protein-free tallow (maximum 24,548 of July 3, 1934, on articles 1 and 2 of Law level of insoluble impurities of 0.15% in weight) number 6198, OF December 26th, 1974, and and derivatives made from this tallow, dicalcium what says the process 21000.008269/2003-65, phosphate (with no trace of protein or fat), hides and considering the necessity of preventing the and skins, gelatine and collagen prepared exclu- entrance of the agent of Bovine Spongiform En- sively from hides and skins. cephalopathy – BSE in the country resolves: Sole Paragraph. The Animal and Plant Art. 1. To prohibit the importation of rumi- Health and Inspection Secretariat can, based on nants, their products and by-products intended risk analysis, exempt other products and inputs. to any means, and veterinary products that con- Art. 4. The Animal and Plant Health and In- tain input from ruminants, when coming from spection Secretariat shall enact complementary countries that have registered domestic cases of instructions when necessary. BSE, or any other country considered as risk for Art. 5. This Normative Instruction will be in the disease by the Animal and Plant Health and force with effect from the date of its publication. Inspection Secretariat. Art. 6. This Normative Instruction revokes 160 Art. 2. It’s also forbiden to import any prod- the Normative Instruction number 15, of July 17, ucts and ingredients of animal origin, when in- of 2001.

ROBERTO RODRIGUES

NORMATIVE INSTRUCTION No. 18 OF DECEMBER 15, 2003

Published in the Official Gazette of December 24, 2003 Section 1, Page 21

Forbids the slaughtering of cattle and buffalo imported form countries where autochthonous cases of BSE have occurred or countries considered at risk of such disease

THE MINISTER OF STATE OF AGRICULTURE, by means of the Decree number 24,548, of July 3, LIVESTOCK AND FOOD SUPPLY, making use of the 1934, and considering the non-occurrence of Bo- prerogative conferred upon him by the art. 87, sole vine Spongiform Encefalophathy – BSE in Brazil, a paragraph, clause II, of the Constitution, bearing condition that must be maintained and preserved, in mind what is determined by the Regulation of for the benefit of the national livestock patrimony, Animal Sanitary Health and Inspection, approved and what is determined by the Process number 21000.010302/2003 - 17, hereby resolves: according to the terms of art. 4. Art. 1. To forbid the slaughtering of cattle Sole paragraph. After the publication of and buffalo imported form countries where au- this Normative Instruction, no indemnification tochthonous cases of BSE have occurred or coun- will be applicable when the country of origin tries considered as risk of such disease. of the imported cattle or buffalo presents an Art. 2. To forbid the commercialization and autochthonous case of BSE or is considered as a transfer to other cattle raising establishments of risk for such disease. the cattle or buffalo cited in the former article, Art. 6. To approve the technical procedures to without a previous authorization from the official be adopted, at the time of instructing the process animal sanitary and inspection service. of sanitary slaughter or sanitary slaughter and in- Art. 3. If animals such as mentioned in art. demnification of cattle or buffalo imported from 1 die, they can only be buried or destroyed after a country considered as a risk of BSE, as listed in communication with the official animal sanitary the Annex I of this normative instruction. health and inspection service and previous au- Art. 7. The Animal Health and Inspection thorization has been obtained from them. It will Department – DDA, of the Animal and Plant carry out the technical procedures recommended Health and Inspection Secretariat – SDA, will be in the annexes to this Normative Instruction. responsible for implementing the procedures ap- Art. 4. All imported cattle or buffalo, whose proved by this Document. country of origin has registered the occurrence Art. 8. The total or partial non-observance of one or more autochthonous cases of BSE, or is of this Normative Instruction will subject the of- considered as risk, once it has lost the attributes fender to the sanctions established in the Brazil- that justify its objective, should be sacrificed and ian Criminal Code. destroyed with the monitoring of the official ani- Art. 9. This Normative Instruction goes into mal sanitary health and inspection service. effect on the date of its publication. Art. 5. Indemnification by the Federal Gov- Art. 10. The Normative instruction number ernment for the owner will be applicable in cases 08, of February 13, 2001 and the Service instruc- of cattle or buffalo imported before the publication DDA number 01, of January 7, 2002 are tion of this Normative Instruction, slaughtered hereby revoked.

ROBERTO RODRIGUES 161

ANNEX I

TECHNICAL PROCEDURES FOR THE SANITARY SLAUGHTER AND INDEMNIFICATION OR SANITARY SLAUGHTER OF CATTLE OR BUFFALO IMPORTED FROM COUNTRIES considered as a RISK OF BOVINE SPONGIFORM ENCEFALOPATHY (BSE)

The process of sanitary slaughter or indem- II) to begin the process of elimination and, when nification of cattle or buffalo imported from a pertinent, of posterior indemnification, attaching country considered to have a risk of BSE, will fol- a copy of the document proving the property of low the technical procedures below: the respective animal; I - the owner of the cattle or buffalo imported II - the cattle or buffalo to be sanitary slaugh- from a country where the occurrence of BSE has terd, for which an indemnification may be re- been registered or considered to have a risk of ceived, should be previously evaluated by a state this infirmity, should communicate, in writing, to commission constituted for that end the Official Veterinary Service of the state where a) this commission will be instituted through the animal is, his desire to eliminate him (annex a Decree from the Federal Agriculture Commis- sioner in the state and comprised of veterinary the animal, as well as the packaging and sending doctors or animal health technicians from the of the collected brain stem to the laboratory indi- executive agency for the activities of animal sani- cated by the DDA for diagnosis of BSE; tary and inspection service of the state and of V - the head of the Animal Heath Service or representatives designated by the association of Section – SSA, will confirm the regularity of all raisers or the state’s agriculture federation. the actions in the records, through a circumstan- b) the objective of the commission will be to tiated technical note. inspect, asses and procede the sanitary slaughter VI - if indemnification is applicable, the Fed- of the animal(s) and, in accordance with the aver- eral Commissioner of Agriculture of the state, age price of the arroba (one arroba corresponds after analyzing the process and receiving the re- to 15 kg) in the region, define the amount to be port from the local Juridical Consultancy, or the paid for the animal(s) sanitary slaughterd. State’s Juridical Consultancy Center, will forward c) the commission should attach to the pro- the process to the Animal Health Department, in cess a document that proves the means through Brasilia, to request the necessary funds. which the quotation of the arroba was obtained. VII - The SDA should, after analyzing the d) the commission will issue a Sanitary conclusive report or the process written by the slaughter Assessment Record (annex III) (Auto de DDA, forward it to MAPA’s Juridical Consultancy, Avaliação de Sacrifício). The owner must agree for its opinion. with the amount to be paid. VIII - Once the process is concluded, wheth- III - when an indemnification is not appli- er or not indemnification is applicable, and cable, only the Sanitary slaughter Record (annex once all the formal procedure has been com- V) should be issued, which will be signed by two pleted, the process should be filed at the DFA, employees of the state’s Animal Sanitary and In- after including the information in the National spection Service. One of them should be a veteri- Databank of the Brazilian System for Identifi- nary doctor. cation and Certification of Cattle and Buffalo IV - whether or no indemnification is appli- – SISBOV (Sistema Brasileiro de Identificação cable, the state’s official service will coordinate e Certificação de Bovinos e Bubalinos), also for the sanitary slaughter, incineration and burial of audit purposes.

162 ANNEX II

REQUEST FOR ELIMINATING ANIMALS

To Mr. ______

I,______, of ______nationality, ______, marital statues ______, profession ______, resident at______, Municipality ______, state ______, holder of the CPF number ______and the do RG number ______, respectfully request the elimination of ______(number) cattle or buffalo imported from countries considered at risk for Bovine Spongiform Encephalopathy (BSE), by the Ministry of Agriculture, Livestock and Food Supply, discriminated below, of which I am the owner. It (They) is (are) at the property named ______, at the municipality ______, state ______, I am based on the art. 4º of the Normative Instruction number 18, of December 15, 2003.

Individual Identification Code Species Gender Breed Country of Origin (SISBOV)

163

______, ______, ______

______Signature of the owner of his legal representative ANNEX III

SANITARY SLAUGHTER ASSESMENT RECORD NUMBER ______/ STATE (when indemnification is applicable)

On the _____of the month of ______of ______, the Assessment and Sanitary slaughter Com- mission, designated through the decree number ______, of ______, _____, of the Federal Commissioner of Agriculture of the state of ______, carried out the assessment for sanitary slaughter of ______(number) cattle imported from countries considered at risk for Bovine Spongiform Encephalopathy (BSE) by the Ministry of Agriculture, Livestock and Food Supply, as established in the item II of the annex I of the Normative Instruction number 18, of december 15, 2003, They exist in the property defined below:

LOCATION AND IDENTIFICATION OF THE PROPERTY / OWNER:

Name of Property: Location: Municipality: ZIP CODE: State: Code of the Property at SISBOV:

Name of Owner: CPF: Nationality: Profession: Address of Owner: Municipality: State: ZIP CODE: 164

ANIMAL(S) FOR WHICH INDEMNIFICATION WILL BE PAID: Individual identifica- Species Gender Breed Country Total of Value per Ar- Total Value (R$) tion code (SISBOV) of Origin Arrobas roba (R$)

GENERAL TOTAL

MEMBERS OF THE COMMISSION Name / Organization Signature: Name / Organization Signature: Name / Organization Signature: ANNEX IV

DECLARATION OF THE OWNER

______(owner) ______(nationality)______(marital status)______(profession), ______(number of the RG), ______(number of the CPF) and ______(address), declares to be in full agreement with the As- sessment Record number _____/____ (state) of ___/___/__ referring to ______(number) animal (s) imported from countries considered to be at risk of Bovine Spongiform Encephalopathy (BSE) by the Ministry of Agriculture, Livestock and Food Supply, in his property, carried out by the As- sessment Commission designated by means of the Decree number______of the Federal Commissioner of Agriculture of the state of ______. The amount was calculated at R$ ______( ______).

______Date and Place

______Signature of the owner or legal representative

165 ANNEX V

SANITARY SLAUGHTER RECORD (indemnification is not applicable)

On the ______day of the month of ______of the year ______, the persons signed below, in fulfillment of item III of the Annex I of the Normative Instruction No. 18 of december 15, 2003, proceeded to the sacrifice and destruction of the animal(s) described below.

LOCATION AND IDENTIFICATION OF THE PROPERTY/ OWNER:

Name of Property: Location: Municipality: ZIP CODE: Unit of the Federation: Property code at SISBOV:

Name of Owner: CPF: Nationality: Profession: Address of owner: Municipality: Unit of the Federation: ZIP CODE:

SPECIES TO BE SANITARY SLAUGHTERD: BOVINE / BUBALINE

GENDER Animal’s individual identification code (SISBOV) NUMBER OF ANIMALS MALE

166 FEMALE

TOTAL NUMBER OF ANIMALS ( ) ______SANITARY SLAUGHTERD

PERSONS RESPONSIBLE FOR THE SACRIFICE AND DESCTRUCTION:

Name /RG / Institution Signature: Name /RG / Institution Signature:

WITNESSES: Name /RG / Institution Signature: Name /RG / Institution Signature: NORMATIVE INSTRUCTION SDA No. 18 OF FEBRUARY 15, 2002

Published in the Official Gazette of february 18, 2002 Section 1, Page 1

Approves the Norms that shall be adopted, aiming to increment the epidemiological surveillance for detection of Transmissible Spongiform Encephalopathies – TSE in ruminants

THE SECRETARY OF AGRICULTURE AND LIVE- Art. 1. Approve the Norms that shall be ad- STOCK HEALTH AND INSPECTION OF THE MINIS- opted, aiming to increment the epidemiologi- TRY OF AGRICULTURE, LIVESTOCK AND FOOD SUP- cal surveillance for detection of Transmissible PLY, using the assignments give to him by article Spongiform Encephalopathies – TSE in rumi- 83, part IV, of the Department Statute, approved nants. by the Ministerial Administrative Ruling number Art. 2. The Animal Health Department, 574, of December 8, 1998, the article 4, of the hearsay the Department of Inspection of Animal Administrative Ruling number 516, of December Origin Products, shall define the necessary pro- 9, 1997, considering what has been determined cedures and rules for the implementation of a by the Animal Sanitary Health and Inspection surveillance system approved by this Normative Regulation, approved by Decree number 24.548, Regulation. of July 3, 1934, and what is registered in process Art. 3. This Normative Regulation will be in number 21000.000439/2002-82, resolves: force with effecto on the date of its publication.

LUIZ CARLOS DE OLIVEIRA

ANNEX

TECHNICAL NORMS OF THE EPIDEMIOLOGICAL SURVEILLANCE SYSTEM FOR DETECTION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES IN RUMINANTS - TSE 167 Art. 1. An active surveillance system shall be IV – the above-mentioned animals will have implemented on slaughtered cattle with official their brain stem collected by the official inspec- inspection, through collection of material for tion service at the time of slaughtering. laboratory tests, according to what follows: Art. 2. The Animal Health Services of the I – the sample definition shall be estab- Federal Agriculture Stations of the states included lished by the Animal Health Department, hear- in this statute surveillance system, shall arrange say the Department of Inspection of Animal the shipment of material collected at the slaugh- Origin Products. ertherhouse to DDA authorized laboratories, for II – the active surveillance system for TSE the carrying out of laboratorial exams. detection in cattle shall be performed in ani- Art. 3. Field epidemiological surveillance mals with more than 30 (thirty) months, and measures shall be intensified through collection are of dairy exploration or intensive or semi- of material in the following cases: intensive systems of beef cattle, as well as of I – Cattle or sheep/goats with clinical signs all cattle or sheep/goats destined to casualty of sub acute nervous disturbance or behav- slaughtering. ioral alterations, with clinical evolution of 15 III – in the sheep/goats case, the collection or more days; of material shall be performed in animals with II – Recumbent cattle or sheep/goats, with more than 12 (twelve) months. no determined cause; III – Cattle or sheep/goats with chronic wast- cattle, and 12 months for sheep and goats, that ing diseases. are negative for rabies, to one of the authorized Art. 4. Surveillance shall be maintained in laboratories by the Ministry of Agriculture, Live- all cattle or sheep/goats with clinical signs of ner- stock and Supply laboratories, for the carrying vous disturbance, according to the Administrative out of BSE diagnosis. Ruling number 516, of December 9, 1997. Art. 5. The surveillance of every bovine im- Sole Paragraph. Every laboratory that diag- ported from countries that had BSE autochthonal noses rabies shall obligatorily send the samples cases shall be done according to the Miniterial of encephalic material from investigated animals Administrative Ruling number 08, of February that are older than 24 (twenty-four) months, for 15, 2001.

COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING No. 14 OF MARCH 15, 2002

Published in the Official Gazette of March 18, 2002, Section 1, Page 36

Establishes the Consultative Scientific Committee on Transmissible Spongiform Encephalopathies-TSEs, whose attributions shall include the following: to provide the Animal Health Department-DDA with technical and scientific inputs; to issue technical opinions; to draft proposals aimed at improving the system for prevention and control of transmissible encephalopathies-TSEs in the country; and to propose norms on TSEs surveillance and prophylaxis.

168 NORMATIVE INSTRUCTION No. 17 OF APRIL 7, 2008

Published in the Official Gazette of April 8, 2008, Section 1, Page 21

Prohibits the manufacturing on the national territory, at the same plant, of products destined for ruminants and non-ruminants feeding, except at establishments that meet the specific requirements.

NORMATIVE INSTRUCTION No. 34 OF MAY 28, 2008

Published in the Official Gazette of May 29, 2008, Section 1, Page 13

Approves the Technical Regulations for Hygiene, Sanitary, and Technological Inspection of the Processing of Animal Residues, and the Form for the Transport of Animal Residues. NORMATIVE INSTRUCTION No. 17 OF JULY 13, 2006

Published in the Official Gazette of July 14, 2006, Section 1, Page 23

Establishes the Operational Norm for the Cattle and Buffalo Production Chain’s Traceability System (SISBOV) and determines the procedures for the authorization of the importation of Cattle and Buffalo.

NORMATIVE INSTRUCTION No. 18 OF FEBRUARY 27, 2004

Published in the Official Gazette of March 23, 2004, Section 1, Page 3

Establishes norms on quality requirements for the accreditation and monitoring of laboratories by MAPA to permit them to perform diagnostics of Transmissible Spongiform Encephalopathies-TSEs in ruminants, through the use of immunohistochemical analysis.

NORMATIVE INSTRUCTION No. 15 OF FEBRUARY 15, 2002

Published in the Official Gazette of March 5, 2002, Section 1, Page 5

Approves the Norms for the accreditation and monitoring of laboratories to perform diagnostic of Transmissible Spongiform Encephalopathies-TSEs in ruminants.

NORMATIVE INSTRUCTION No. 6 OF FEBRUARY 26, 1999 169 Published in the Official Gazette of March 2, 1999, Section 1, Page 61

Establishes the sanitary situation evaluation form hereto annexed for all countries where there have been occurrences of Transmissible Spongiform Encephalopathies, with which Brazil maintains trade in animals and in animal parts and byproducts.

JOINT DDA/DIPOA SERVICE INSTRUCTION No. 2 OF AUGUST 15, 2003

Determines that all slaughter/packing houses, slaughterhouses, and small- and medium- size-animal slaughterhouses with federal inspection service-SIF that slaughter cattle and/or sheep/goats must participate in the surveillance of transmissible spongiform encephalopathies-TSEs in animals of these species, which are destined for emergency slaughter. DOI/DIPOA SERVICE INSTRUCTION No. 2 OF AUGUST 12, 2003

Provides for procedures and norms for the operationalization of the epidemiologic surveillance system for the detection of Transmissible Spongiform Encephalopathies-TSEs in ruminants.

DOI/DIPOA SERVICE INSTRUCTION No. 1 OF MARCH 7, 2002

Procedures and norms for the operationalization of the epidemiologic surveillance system for the detection of Transmissible Spongiform Encephalopathies-TSEs in ruminants.

INTERNAL NORM DSA No. 2 OF AUGUST 23, 2005

Establishes procedures for tracing, monitoring, and identifying imported bovines.

INTERNAL NORM DSA No. 1 OF MAY 17, 2005

Determines the adoption of an active surveillance system for detecting animal protein in ruminant animal feed at animal-raising establishments. The additional procedures and instructions for the collection of the requisite samples are set forth in the “Manual on the Collection of Samples of Ruminant Animal Feed for Detection of Animal Protein.”

170 NATIONAL AVIAN HEALTH PROGRAM

ADMINISTRATIVE RULING No 147 OF JUNE 14, 2006

Published in the Official Gazette of June 16, 2006 Section 1, Page 3

Establishes a Consultative Technical Committee to help draft technical proposals pertaining to Avian Influenza and Newcastle Disease.

THE MINISTRY OF AGRICULTURE, LIVE- ceeding No. 21.000.004416/2006-71, STOCK AND FOOD SUPPLY’S DEPUTY AGRICUL- RESOLVES: TURE AND LIVESTOCK HEALTH AND INSPEC- Art. 1. To establish a Consultative Techni- TION, by virtue of the powers conferred on cal Committee to help draft technical propos- him under Art. 42 of Annex I to Decree No. als pertaining to Avian Influenza and Newcastle 5351 of January 21, 2005 and in view of Pro- Disease. Art. 2. The aforementioned Committee’s search Enterprise-CNPSA/EMBRAPA: membership shall consist of the following repre- a) Liana Brentano; sentatives: VIII – Santa Maria Federal University-UFSM: I – Brazilian Poultry Farming Union-UBA: a) Luiz Fernando Sangoi; a) Alberto Back; and IX – Vale do Rio dos Sinos University-UNISI- b) Nelva Grando; NOS: II – Rio Grande do Sul Federal University- a) Martin Sander; UFRGS: X – Uberlândia Federal University-UFU: a) Carlos Tadeu Pippi Salle a) Paulo Lourenço da Silva; III – Campinas State University-UNICAMP: XI – Pernambuco Federal Rural University- a) Clarice Arns; UFRPE: IV – São Paulo University-USP a) Severino Mendes de Azevedo Júnior. a) Edison Luis Durigon; and Art. 3. The Committee shall be chaired b) Leonardo José Richtzenhain; by the Director of the Animal Health Depart- V – São Paulo State University-UNESP: ment. a) Hélio José Montassier; Art. 4. The Committee’s Chairman may call VI – Brazilian Environmental Institute- upon technical personnel from either the private IBAMA: or the public sector, as needed, for additional ad- a) João Luiz Xavier do Nascimento; visory services. VII – National Center for Swine and Poultry Art. 5. This Administrative Ruling shall enter Research-Brazilian Agricultural and Livestock Re- into force on the day of its publication.

NELMON OLIVEIRA DA COSTA

ADMINISTRATIVE RULING No. 542 OF NOVEMBER 16, 1998

Published in the Official Gazette of November 17, 1998 Section 1, Page 89

Provides for Hygiene and Sanitary Norms for Qualification of Poultry Farming and Poultry 171 Hatchery for Trade within MERCOSUR.

THE MINISTER OF AGRICULTURE, LIVESTOCK Market Group’s decision is to facilitate trade in AND FOOD SUPPLY, by virtue of the powers vest- one-day old chicks and embryo eggs, ed in him under Art. 87, Sole paragraph, II of the RESOLVES: Federal Constitution and pursuant to Administra- Art. 1. To adopt the “HYGIENE AND SANI- tive Ruling No. 116 of February 29, 1996; having TARY NORMS FOR QUALIFICATION OF POULTRY in view the Asunción Treaty; the Ouro Preto Pro- FARMING AND POULTRY HATCHERY FOR TRADE tocol; Decision No. 6/96 of the Common Market WITHIN MERCOSUR” hereto annexed, which have Council; Resolution no. 91/93 of the Common been approved under Common Market Group- Market Group; and Recommendation no. 12/95 GMC Resolution No. 10/96. of Working Subgroup-VIII on Agriculture; and Art. 2. This Administrative Ruling shall enter considering that the objective of the Common into force on the day of its publication.

FRANCISCO SÉRGIO TURRA ANNEX

HYGIENE AND SANITARY NORMS FOR QUALIFICATION OF POULTRY FARMING AND POULTRY HATCHERY FOR TRADE WITHIN MERCOSUR

CHAPTER I as vehicle wheel disinfection points, and vehicle cleaning and disinfection equipment; Preliminary dispositions d) Poultry sheds must be wooden so that all interior surfaces are smooth and washable to al- Art. 1. The application of the norms herein low proper cleaning and disinfection; and shall be incumbent on the Official Veterinary Ser- e) Poultry sheds and egg storage facilities vices of the MERCOSUR States-Parties. must be insect-free and not accessible to wild Art. 2. The approved norms shall be applied fowl and other wild or domestic animals. at poultry establishments engaged in the region- Art. 7. Breeding nucleus must be free of the al MERCOSUR trade of day-old birds and hatching following: eggs for incubation. a) Pullorum disease and Fowl typhoid (Sal- Art. 3. Poultry Farming Establishments en- monella pullorum and Salmonella gallinarum); gaged in the regional trade in day-old birds and and hatching eggs for incubation must be registered b) Avian mycoplasmosis (Mycoplasma gal- with and qualified by the official services and lisepticum and M. synoviae in hens, and M. me- shall operate under the responsibility of an ac- leagridis, M. synoviae, and M. gallisepticum in credited veterinary doctor. turkeys); Art. 4. For the purposes of registration and Art. 8. Poultry farming establishments must qualification, poultry farming establishments be subject to a permanent epidemiologic surveil- shall be classified into two categories: lance system, i.e., must be controlled by an of- a) Parent, grandparent, and great-grandpar- ficial service. ent breeding nuclei; and Art. 9. While establishments have been un- b) Hatchery. der permanent epidemiologic surveillance, no case of the following diseases was detected: 172 CHAPTER II a) Duck Virus Hepatitis; b) Chicken Infection Anemia; Breeding Establishments c) Swollen head syndrome by pneumovirus; d) Salmonella enteritidis; and Art. 5. For the purposes hereunder a breed- e) Salmonella typhimurium. ing nucleus is understood as a nucleus consist- Art. 10. Criteria for determining that an es- ing of one or more than one lot of parents, tablishment is free of Pullorum disease and Fowl grandparent or great-grandparent of the same typhoid as well as mycoplasmosis shall be ap- age, housed in different sheds under the same proved by MERCOSUR’s Health Committee, and management. shall include the following: Art. 6. The parents, grandparents, and great- a) Types of laboratory diagnostic tests; grandparents breeding nucleus should meet the b) Antigens to be utilized; following requirements: c) Frequency and scope of laboratory diag- a) Be located on a geographically adequate nostic tests; and site to facilitate hygiene and sanitary control; d) Qualified or accredited laboratories. b) Be protected by security fences with only Art. 11. Poultry must be vaccinated against one entry point; infectious diseases according to a scheme ad- c) Have one access gate for strict control of opted by each establishment in conformity with the movement of vehicles and people, as well its epidemiologic status and the epidemiologic situation of the region where it is located. The Art. 18. Day-old birds must be vaccinat- vaccines to be used must be approved and con- ed against the Marek’s disease before being trolled by the official services. shipped, with vaccines made from Specific Pathogen Free-SPF eggs and officially approved CHAPTER III by the exporting country. Art. 19. Day-old birds must be shipped Hatchery. from the incubation establishment to the destination by personnel wearing clean, disinfected Art. 12. Hatchery shall accept solely hatch- protection closing. Transport vehicles must be ing eggs from establishments qualified for the clean and disinfected prior to any shipment of production of day-old birds of a single species. day-old birds. Art. 13. Incubation facilities must be properly built so as to facilitate hygiene and sanitary CHAPTER VI control and must have biosecurity systems pertaining to the transit of people, vehicles, and General Dispositions equipment, as well as to the protection of eggs and chicks to ensure the sanitary quality required Art. 20. Breeding and Hatchery establish- hereunder. ments must keep a thorough zoosanitary record (mortality, disease diagnostics, treatments, vac- CHAPTER IV cination, and monitoring) pertaining to each lot of birds and hatching eggs, to be shown to the Hygiene and transport of veterinary authorities upon request. Hatching eggs Art. 21. The types of laboratory tests to be performed for diagnosing the diseases re- Art. 14. Hatching eggs must be collected at ferred to hereunder shall be agreed with the regular intervals at least four times a day into Committee. clean, disinfected containers. Art. 22. Day-old bird and hatching eggs ex- Art. 15. After collection, the clean eggs must ports should be accompanied since their origin be fumigated or disinfected as soon as possible by a MERCOSUR Member Countries’ Common according to the techniques recommended in An- Zoosanitary Certificate issued by an accredited 173 nex 4.2.4 of the International Epizooties Organi- veterinary doctor and endorsed by an official vet- zation’s International Zoosanitary Code (OIE, Ed. erinary doctor of the country of origin, pursuant 1992) accepted by the Committee. to the form shown in the Annex hereto. Art. 16. Eggs must be transported to the na- Art. 23. Day-old bird and hatching eggs ex- tional or regional hatchery in new, clean, previ- ports shall be suspended in case of noncompli- ously fumigated or properly disinfected contain- ance with the conditions hereunder or of detec- ers. Transport vehicles must be also clean. tion of any transmissible disease at the breeding or Hatchery, or in the region where they are lo- CHAPTER V cated, susceptible of placing the sanitary situation of the importing country at risk. Hygiene and handling of Art. 24. The Official Veterinary Services shall eggs and day-old birds make periodical inspection visits to the breeding and Hatchery registered and qualified for region- Art. 17. Personnel in charge of handling eggs al trade. in the hatcheries, sexing, and handling of day-old Art. 25. For this norm’s certification a de- birds must follow the general personal hygiene tailed Manual of Procedures for Qualification of guidelines, and put on clean clothing and shoes Poultry Farming Establishments (Breeding and In- before beginning their work. cubation) for Regional Trade, should be issued. Art. 26. Breeding nuclei reserved for parents, days have elapsed since declaration of the last grandparents or great-parents must be located in case of the disease and the method of sanitary Newcastle Disease Free Areas. For the purposes slaughter has been employed, without vaccina- of this article, Newcastle Disease Free Areas are tion, as a control measure; and characterized as follows: c) said territory must be subject to a per- a) a legally defined geographical territory manent epidemiologic surveillance system that extending for less than 10 km around the estab- takes into account the following: lishment; - a register of all poultry establishments lo- b) no case or evidence of the disease has cated within a circumscribed area; been detected on said territory for a period of at - a monitoring procedure and serologic sur- least six months and on which vaccination is used veys pursuant to a statistical design; and as a control method. Or at least 21 (twenty one) - an information and analysis system in place.

EXPORTING COUNTRY ...... MINISTRY: ...... SERVICE : ...... COMMON ZOOSANITARY CERTIFICATE FOR DAY-OLD BIRDS AND HATCHING EGGS EXPORTS CERTIFICATE No.: ...... DATE ISSUED : ...... EXPIRATION DATE : ...... (Valid for ten days) I – IDENTIFICATION: ( ) DAY-OLD BIRDS ( ) HATCHING EGGS Species...... Trademark / Breed:...... Classification : ( ) grandparents ( ) parents ( ) Commercial ( ) great-grandparents Lineage : ( ) broiler ( ) laying Quantity : male line male ...... female line male ...... 174 male line female ...... female line female ...... commercial broiler ...... laying ...... TOTAL: ...... II – ORIGIN: Exporter’s name and address ...... Establishment of origin’s name and address :...... Place of shipment : ...... Means of transportation:...... Airline and Flight No. :...... Registration No...... III – DESTINATION Destination country ...... Importer’s name and address...... Destination establishment’s name and address ...... Point of entry in the country :...... IV- OBSERVATIONS: V – SANITARY INFORMATION: The undersigned official veterinarian CERTIFIES that: 1. The ...... day-old birds and ...... hatching eggs originate in the ...... breeding nucleus and in the ...... incubation establishment, which are qualified, regularly inspected by the veterinary services and have not had in the last six months any clinical manifestation of the Newcastle or Gumboro Diseases, Avian Infectious Bronchitis, Avian Infectious Laryngotracheitis, Fowl Cholera, or any other transmissible disease subject to mandatory notification. 2. Permanent epidemiologic surveillance has not detected the presence of Inclusion Body Hepatitis, Avian Infectious Anemia, Swollen Head Syndrome by Pneumovirus, Salmonella enteritidis, or Salmo- nella typhimurium. 3. The aforementioned items originate in breeding nuclei and Hatchery free of: (a) Pullorum disease and Fowl typhoid (S. pullorum and S. gallinarum); (b) Avian mycoplasmosis (M. gallisepticum and M. synoviae in hens, M. meleagridis, M. sinoviae, and M. gallisepticum in turkeys). 4. The day-old birds have been vaccinated against Marek’s disease on ...... , with a type ...... vaccine from the ...... laboratory, included in lot no...... 5. The day-old birds were inspected on the shipment date and showed no clinical signs of disease. 6. The eggs and birds were packaged in clean containers provided with clean separators. 7. The country if free of Avian Influenza (Avian Pest) and the zone is free of Newcastle Disease.

Place and date: ...... Accredited veterinarian’s name and registration nº.: ...... Official stamp: ...... 175 Official veterinarian’s name and registration nº.: ...... ADMINISTRATIVE RULING No. 115 OF OCTOBER 4, 1995

Published in the Official Gazette of October 10, 1995, Section 1, Page 15817

Defines the attributions of the National Avian Health Policy-PNSA’s Scientific Committee

THE Animal and Plant Health and In- relation to the conduction of the National Avian spection Secretary, by virtue of the powers Health Policy; evaluation of the performance vested in him under Art. 78, VII of this Office’s of the public and private sectors; confirmation Internal Regulations approved under Ministerial and control of outbreaks of Newcastle disease, Ruling No. 212 of August 21, 1992, and Art. 2 of Avian Influenza, and other diseases that affect Ministerial Ruling No. 193 of September 19, 1994, state and international trade as well as public having in view the norms and attributions of the health; work methodology in laboratories and National Avian Health Program’s Consultative in animal health and inspection; decisions re- Committee established under SDA Administrative garding intervention and sanitary measures; Ruling No. 114 of October 4, 1995, and evaluation and analysis of other issues as RESOLVES: determined by the Animal and Plant Health and Art. 1. It shall be incumbent on the Com- Inspection Secretary. mittee to provide technical and scientific ad- Art. 2. This Administrative Ruling shall enter visory services to the Ministry of Agriculture, into effect on the day of its publication. All dispo- Food Supply, and Agrarian Reform-MAARA in sitions to the contrary are hereby revoked.

ÊNIO ANTÔNIO MARQUES PEREIRA

ADMINISTRATIVE RULING No. 193 OF SEPTEMBER 19, 1994

Published in the Official Gazette of September 22, 1994 Section 1, Page 14309 176 Institutes the National Avian Health Program, in the sphere of the Animal and Plant Health and Inspection Secretariat – SDA and creates the Advisory Committee for the Avian Health Program

The Minister of Agriculture, Food Supply, enable the implementation of combat/eradication and Agrarian Reform, using the powers invested strategies for the main avian diseases; in him under Art. 87 of the Constitution, in con- The possibility and convenience of establish- sideration of: ing co-management programs for public and pri- The importance of avicultural production for vate institutions, resolves: the country’s economy: Art. 1. To institute the National Avian Health The technological progress obtained by the Program, in the sphere of the Animal and Plant private sector, ranking Brazil as the second coun- Health and Inspection Secretariat – SDA, involv- try in the international market of poultry meat; ing the Animal Health and Inspection Depart- The structure of public and private veteri- ment – DDA, and the Department of Inspection nary services that support the sector in the field, of Products of Animal Origin – DIPOA. laboratory and inspection areas; Art. 2. To delegate authority to the Animal The current sanitary status of aviculture, which and Plant Health and Inspection Secretary to issue norms for the control/eradication of the main Sole paragraph. The Board will be presid- avian diseases, as well as for establishing priority ed over by the Titular of the Animal and Plant areas and strategies. Health and Inspection Secretariat (SDA) and have Art. 3. To create the Advisory Committee for the Director of SDA’s Animal Health and Inspec- the Avian Health Program, delegating authority tion Department as secretary. to the Animal and Plant Health and Inspection Art. 4. This Administrative Ruling comes into Secretary to define which entities will be repre- force on the date of its publication, and all provi- sented in it. sions to the contrary are revoked.

SYNVAL GUAZZELLI

ADMINISTRATIVE RULING No. 70, OF MARCH 3, 1994

Published in the Official Gazette of March 03, 1994 Section 1, Page 3168

Regulates the enforcement of notification of suspected Newcastle Disease.

The Minister of Agriculture, Food Supply, species under their guard or custody, who are and Agrarian Reform, using the powers invested informed of the occurrence or suspect the occur- in him under Art. 87, I, of the Constitution, and rence of Newcastle Disease, are under the obliga- sole paragraph of Art. 61 of the Animal Sanitary tion to immediately notify the state or federal an- Health and Inspection Service Regulation, ap- imal sanitary health and inspection service of the proved by Decree No. 24.548, of July 3, 1934, re- jurisdiction about the fact, suspending all transit solves: of birds existing in the infected, or supposedly Art. 1. To alter the list of sanitary diseases infected establishment, as well as of products of set forth by Art. 61 of the Animal Sanitary Health the birds and of sundry materials that may have and Inspection Service Regulation, approved by had contact with them, until the relevant sani- Decree No. 24.548, of July 3, 1934, to include tary authority decides on which measures should avian Newcastle Disease. be adopted. 177 Art. 2. Veterinarians and all owners, deposi- Art. 3. This Administrative Ruling comes taries, or individuals who maintain birds of any into force on the date of its publication.

SYNVAL GUAZZELLI

NORMATIVE INSTRUCTION No. 56 OF DECEMBER 4, 2007

Published in the Official Gazette of December 06, 2007 Section 1, Page 11

Establishes Procedures for the Registration, Inspection and Control of Comercial and Poultry Breeding Establishments

THE MINISTER OF STATE OF AGRICULTURE, the provisions of the Animal Health Defence LIVESTOCK AND FOOD SUPPLY, exercising the Service Regulations approved by Decree No. powers conferred upon him by Article 2, De- 24548 of July 3, 1934 and the provisions of Pro- cree No. 5741 of 30th March, 2006, considering ceedings No. 21000.008132/2005-72 and No. 21000.008133/2005-17, resolves: Art. 2. Normative Instruction MAPA No. 4 of Art. 1. To establish PROCEDURES FOR THE December 30, 1998 is hereby revoked. REGISTRATION, INSPECTION AND CONTROL OF Art. 3. This Normative Instruction shall COMMERCIAL AND POULTRY BREEDING ESTAB- come into force on the date of its publication. LISHMENTS, in the form of its attachments.

REINHOLD STEPHANES

ATTACHMENT I

PROCEDURES FOR THE REGISTRATION, INSPECTION AND CONTROL OF COMMERCIAL AND POULTRY BREEDING ESTABLISHMENTS

CHAPTER I laying up to 20 weeks old; VII – HATCHERY ESTABLISHMENTS FOR PURE GENERAL PROVISIONS LINE FARMS: importer, exporter and producer establishment of day-old birds for grandparent Art. 1. The present Normative Instruction de- production; fines procedures for the registration, inspection VIII – HATCHERY ESTABLISHMENTS FOR and sanitary control of Commercial and Poultry GREAT-GRANDPARENT BREEDING FARMS: import- Breeding Establishments, with the exception of ers, exporters and producers of day old birds for the breeding of ratites. the production of grandparents; Art. 2. For the purposes of registration and IX – HATCHERY ESTABLISHMENTS FOR inspection, poultry breeding establishments shall GRANDPARENT BREEDING FARMS: importing, ex- be classified according to their purpose, accord- porting and producing establishment of day old ing to the species being breed – chicken, teal, birds for the production of parents; duck and turkey, in the following categories: X – HATCHERY ESTABLISHMENTS FOR PAR- I - PURE LINE ESTABLISHMENTS: farm or nu- ENT BREEDING FARMS: importing, exporting and cleus where there is genetic selection of primary producing establishment of day old birds, broil- 178 breeders, importer, exporter and producer of hatchers and commercial egg-laying hens; ing eggs for production of great-grandparents; XI – ESTABLISHMENT PRODUCER OF SPF – II - GREAT-GRANDPARENT BREEDING ESTAB- SPECIFIC PATHOGEN FREE POULTRY AND EGGS; LISHMENT: great-grandparent farm or nucleus, XII – ESTABLISHMENT PRODUCER OF EGGS importer, exporter and producer of hatching eggs CONTROLLED FOR THE PRODUCTION OF INACTI- for production of grandparents; VATED VACCINES. III – GRANDPARENT BREEDING ESTABLISH- Art. 3. For the purposes of registration and MENT: grandparent farm, importer, exporter and inspection, COMMERCIAL POULTRY ESTABLISH- producer of hatching eggs for the production of MENTS shall be classified as to their purposes in parents; three categories: IV – PARENT BREEDING ESTABLISHMENT: I - COMMERCIAL BROILER ESTABLISHMENTS: parent farm or nucleus, importer, exporter and Establishments exploiting commercial poultry producer of hatching eggss for the production of for the production of chicken (Gallus gallus do- commercial broilers or egg-laying hens; mesticus) and turkey (Meleagris gallopavo) for V – PARENT RAISING ESTABLISHMENT: day- slaughter. old parent raising farm or nucleus producer of II - COMMERCIAL EGG-LAYING ESTABLISH- commercial broilers and egg-laying hens; MENTS: Establishments exploiting commercial VI – RAISING ESTABLISHMENT: raising farm poultry for the production of chicken eggs (Gallus or nucleus for day-old birds for commercial egg- gallus domesticus) for consumption. III - BREEDING ESTABLISHMENTS FOR tion procedures with the Ministry of Agriculture, OTHER POULTRY NOT CONTEMPLATED IN THE Livestock and Food Supply, within a maximum of PREVIOUS DEFINITIONS, EXCEPTION MADE TO 1 (one) year. RATITES: Art. 8. The state animal health and inspec- Establishments exploiting other production tion bodies in states participating in the National fowl, considered exotic or not, exception made to Avian Health Program must register the Commer- ratites and their hatcheries, not contemplated in cial Poultry Establishments described in Article 3 the poultry meat and egg production system. of this Normative Instruction. Art. 4. Commercial and Poultry Breed- Sole Paragraph. Pre-existing Commercial ing Establishments may be epidemiologically Poultry Establishments must adapt to the registra- formed by: tion procedures with the state animal health de- I - NUCLEUS: physical poultry production fence bodies within a maximum of 2 (two) years. unit composed by one or more sheds housing a Art. 9. In order to register, the poultry es- group of birds of the same species and age. The tablishments must be registered with the local nuclei must have a common production manage- veterinary attention unit of the state animal ment and must be isolated from other poultry health and inspection service in the form of the production activities by using natural or artificial ATTACHMENT II to this Normative Instruction and physical barriers; its owners must present the following documents II - FARM: physical poultry production unit to the body responsible for the registration: housing a group of birds of the same species. I – Request to the registration body, in the The farms must be subjected to a common pro- form of ATTACHMENT III or IIIA of this Normative duction management and must be isolated from Instruction, depending on the case; other poultry production activities by natural or II – Legal Entity legal existence data: artificial physical barriers, composed by one or a) copy of the CNPJ (National Register of Cor- more production nuclei. porate Taxpayers) card; Art. 5. A pre-existing poultry establishment is b) copy of registration at the State Commer- a poultry farm that had been physically installed cial Registry or of the company’s Articles of Asso- before the date of publication of this Normative ciation, together with any changes made; Instruction. c) copy of the leasing agreement or partner- Art. 6. The poultry and the genetic material ship agreement registered at the registry office, 179 housed in the Poultry Establishments described if any. in this Nornative Instruction must come from III – Individual legal existence data: registered establishments subjected to sanitary a) copy of the CPF (Individual Taxpayer Reg- monitoring by the Ministry of Agriculture, Live- istration) card; stock and Food Supply. b) copy of registration with INCRA (National Institute of Colonisation and Agrarian Reform) or CHAPTER II copy of the property’s inscription with the Fed- eral Revenue; REGISTRATION OF POULTRY c) copy of the inscription declaration of rural ESTABLISHMENTS producer; d) copy of the leasing contract or partnership Art. 7. The poultry breeding establishments deed registered in the registry office, if any. described in Article 2. of this Normative Instruc- IV – Note of technical responsibility of the tion shall be registered with the Ministry of Agri- Veterinarian carrying out the hygiene-sanitary culture, Livestock and Supply - MAPA. control of the poultry establishment, following Sole Paragraph. Poultry breeding establish- the model of the Regional Veterinary Medicine ments pre-existing the date of publication of this Council; Normative Instruction must adapt to the registra- V – Plant showing the property’s location, signed by a professionally qualified technician, where the establishment is located, in the form indicating all premises, roads, watercourses, bor- of ATTACHMENT IV of this Normative Instruction. dering properties and respective activities in a Paragraph 2. For the registration of Commer- scale compatible with the size of the property, or cial Poultry Establishments, the documents listed an aerial survey; In the case of Commercial Poul- in items I to VIII should be presented together try Establishments, the sketch or aerial survey with a Physical and Sanitary Inspection Expert will be required, showing all installations, water- Report issued by the Official Veterinarian of the courses and bordering properties; Local Veterinary Attention Unit, in the form of VI – Floor plan of the installations in a scale ATTACHMENT IVA of this Normative Instruction. compatible with the visualisation of the infra- Paragraph 3. After issuing the poultry estab- structure installed; lishment’s registration certificate in the form of VI – Licence issued by a municipal, state or Attachment V of this Normative Instruction, the federal environment inspection body, approving document should be made available for inspec- the area where the establishment is to be built; tion at the establishment. VII – List of hygiene-sanitary and biosecurity Paragraph 4. The Commercial and Poultry measures to be adopted by the poultry establish- Breeding Establishments should communicate ment and of the technological processes, includ- any changes to the technical expert in charge to ing a detailed description of the following: the body issuing the registration within a maxi- a) adopted management; mum of 30 (thirty) days, and present the corre- b) location and isolation of premises; sponding documentation of the successor. c) natural barriers; Paragraph 5. Any change of address, com- d) physical barriers; pany name or improvements to the company’s e) access control and transit flow; physical structure, as well as the alienation or f) care with feed and water; lease of the Establishment must be obligatorily g) poultry health programme; updated at the registration body by: h) contingency plan; I – presenting a request o update the regis- i) personnel qualification plan; tration status; j) environment management plan; and II – presenting a copy of the new articles of l) descriptive plan of the traceability of hatch- association of the poultry establishment or the ing eggs and the destination of non-hatching leasing contract; and 180 eggs, required only of hatcheries, producers of III – inspection of the physical area and SPF poultry and eggs, and producers of controlled hygiene-sanitary control carried out by the body eggs for the production of inactivated vaccines. responsible for the registration. VIII – document proving the microbiological, physical and chemical quality of the drinking wa- CHAPTER III ter, according to sanitary surveillance standards, or a certificate of use of water from public water INSPECTION supply services. Paragraph 1. For the registration of poultry Art. 10. The Poultry establishments covered breeding establishments, the documents listed in by this Normative Instruction must be located in items I to VIII of this article should be presented an area not subject to adverse conditions that together with a Physical and Sanitary Inspection may interfere in the health and well-being of the Expert Report issued by an Agricultural and Live- birds and the quality of the product, respecting stock Federal Inspector (FFA) with the approval of the following minimal distances between the the Agricultural and Livestock Health and Inspec- poultry establishment and other locations at tion Service and the Agricultural and Livestock sanitary risk: Inspection Service (SEFAG) of the Federal Super- I - 3 Km (three kilometres) between a breed- intendence of Agriculture at the federation unit ing poultry establishment and abattoirs of any purpose, feed mills, other poultry breeding or Paragraph 2. Poultry breeding establish- commercial establishments; ments using sheds closed with a screen mesh over II – internal limits of the poultry establish- 2 cm (two centimetres) shall have 5 (five) years ment producer of SPF eggs and birds, and pro- to change their screens to a mesh not over 2 cm ducer of controlled eggs for the production of (two centimetres). During this period, other bios- inactivated vaccines: ecurity and management measures provided for a) 500 m (five hundred metres) between dif- in this Normative Instruction must be adopted. ferent age nuclei, between raising and produc- Art. 12. SPF Poultry and Egg Producing Es- tion sheds, and between the nucleus and the tablishments should have masonry sheds, includ- vicinal road, state or federal highway; ing their walls, so as to allow their cleaning and b) 200 m (two hundred metres) between the disinfection, and these should be fitted with an nuclei and the peripheral limits of the property; absolute air filtering system maintaining a con- III. internal limits of other poultry breeding stant positive pressure. establishments: Art. 13. Controlled Egg Producing Establish- a) 200 m (two hundred metres) between the ments for the Production of Inactivated Vaccines nuclei and the peripheral limits of the property; should have curtains to enable the air to flow b) 300 m (three hundred metres) between in one direction, and a system that assures that the nuclei. the air enters the premises from one source only, Paragraph 1. The establishment’s accredited through the installation of devices that allow the laboratory, if it exists, must be located outside monitoring of air quality. the fence isolating the production nuclei. Art. 14. The Commercial Poultry Establish- Paragraph 2. Changes to the minimum dis- ments facilities should be built with materials that tances mentioned in this article may be accepted allow their cleaning and disinfection and they by SEFAG/SEDESA-Federal Superintendence of should be provided with protection against the Agriculture in the case of pre-existing establish- outside environment, including the installation ments and based on risk assessment for poultry of screens with a mesh measuring not over 2 cm health, as a result of the adoption of new tech- (two centimetres), to guard against the entrance nologies, the existence of natural barriers (refor- of birds, domestic animals and wild animals. estation, natural forests, topography) or artificial Paragraph 1. Commercial broiler establish- barriers (brick walls), and the use of manage- ments and commercial egg-laying establishments 181 ment techniques and differentiated biosecurity should have an isolating fence at least 1.5 m (one measures that make the introduction and the and a half metres) tall surrounding the shed or dissemination of disease agents difficult. nucleus, standing at least 5 m (five metres) away Art. 11. Poultry breeding establishments from the building, so as to prevent the transit and should be built in such a manner that their in- presence of animals from other species within its terior shed surfaces can be cleaned and disin- perimeter. fected, that their have a masonry floor, that their Paragraph 2. Commercial egg producing sheds are provided with protection against the establishments, as well as adopting measures external environment, including the installation to prevent the presence of birds with unknown of screens with a mesh not over 2 cm (two cen- sanitary status, flies and rodents around and in- timetres), to guard against the entrance of birds, side the shed, should avoid wasting feed, adopt domestic animals and wild animals. measures to ease the quick desiccation of faeces, Paragraph 1. Poultry breeding establish- avoiding the accumulation of insects and their ments should have an isolation fence of at least larvae, and to avoid humidity in birds faeces by 1.5 m (one and a half metres) tall surrounding the controlling leakages from waterers and other washed or the nucleus, standing at 10 m (ten metres) ter sources. from it, keeping the transit and presence of ani- Paragraph 3. Pre-existing Commercial Poul- mals from other species outside its perimeter. try Establishments shall be given a 5-year period from the date this Normative Instruction is pub- shall be divided at least into: lished to install screens with a mesh not over 2 I - dressing rooms, lavatories and toilets at cm (two centimetres) over the shed’s external nuclei entrances; open niches. II - office; Paragraph 4. Establishments breeding other III - egg storage room; production birds and ornamental birds should be IV - supplies room; provided with screens with a mesh not over 2 cm V - fumigation chamber for supplies and (two centimetres) to avoid the entrance of birds, equipment; and domestic and wild animals. Open air breeding VI - vehicle cleaning and disinfection area. facilities should have the upper part of the pad- Art. 18. The internal area of the hatchery docks fitted with screens. shall be divided into book-keeping and technical Paragraph 5. Ornamental bird establish- areas, physically separated, both with individual ments already using sheds closed with screens ventilation and unidirectional air flow. The work with a mesh over 2 cm (two centimetres) shall be area shall be provided with a single access for given a period of 5 (five) years to replace them people, equipment and supplies. with meshes not over 2 cm (two centimetres). Sole Paragraph. The technical premises of Paragraph 6. The transit or presence of the hatchery shall be divided at least into: animals of other species inside production and I - egg reception room; ornamental bird breeding establishments is not II - egg disinfection chamber; permitted. III - egg storage room; Art. 15. The premises of SPF Egg and Bird IV - hatchery room; Producing Establishments shall be divided at V - hatching room; least into the following areas: VI - room with areas for selection, sexing, I – dressing rooms, lavatories and toilets; vaccination, packing and stocking of chicks; II - office; VII - chick dispatch room; III - depot; VIII – vaccine manipulation room; IV - chick area; IX - equipment washing and disinfection V - production area: room; VI - hatchery area; X - dressing rooms, lavatories and toilets; VII - supplies area; XI - refectory; 182 VIII - egg fumigation chamber; XII - office; IX - fumigation chamber for supplies enter- XIII - boxes depot; and ing the farm; XIV - machines and generators room. X - boxes and trays depot; and Art. 19. All animal feed and water introduced XI - egg classification and storage room. in the SPF Eggs and Poultry Production Establish- Art. 16. The premises of Controlled Egg Pro- ment shall receive treatments to eliminate the duction Establishments for the Production of In- possibility of entrance of pathogens through ster- activated Vaccines shall be divided at least into: ilisation mechanisms with the use of autoclave I - dressing rooms, lavatories and toilets; for feed and filter for water; the same is valid for II - office; any other material introduced in the premises, III - depot; which shall be subjected to treatment allowing to IV - egg fumigation chamber; eliminate contamination by pathogen agents. V - fumigation chamber for supplies enter- Art. 20. Any visits to commercial and poultry ing the farm; breeding establishments by persons strange to VI - boxes and trays depot; and the production process shall be preceded by the VII - egg classification and storage room. same procedures to which the establishment’s Art. 17. Apart from the production area, personnel is subjected, such as showering and the premises of poultry breeding establishments change of clothes and shoes at the entrance of the establishment and at each nucleus. Administrative Ruling No. 518 of March 25, 2004 Sole Paragraph. The visitor and the official within the following periods: veterinarian shall sign a term of responsibility a) Annual physical and chemical analysis where they affirm not to have had any contact and bacteriological analysis every three months with any type of bird for a minimum period of 7 for establishments producing SPF eggs and birds days for SPF Egg and Poultry Establishments and and eggs controlled for the production of inactive Controlled Egg Establishments for the Production vaccines. of Inactivated Vaccines, 3 days for Pure Line Es- b) Annual physical and chemical analysis tablishments, Great-grandparent and Grandpar- and bacteriological analysis every semester for ent Establishments and 1 day for Parent Estab- further poultry breeding establishments. lishments, prior to entering the establishment or c) Annual physical. chemical and bacte- each nucleus. riological analysis for commercial bird establish- Art. 21. Commercial and Poultry Breeding ments. Establishments shall adopt the following actions: IX – to keep for a period not under 2 (two) I – to control and register the movement of years at the disposal of the official service, the vehicles and the access of persons to the estab- registers of: lishment, including the placement of warning a) bird movement activities (copies of the signs to avoid the entrance of persons strange to Animal Movement Permits); the production process; b) sanitary actions carried out; II – to be protected by security fences and by c) vaccination protocols and medicines used; different ways of access for vehicles and persons, and contemplating an entrance for cleaned and dis- d) visit dates and recommendations by the infected material to be used in the production, Technical Person in Charge and by the official and another for the removal of discarded mate- veterinarian. rial and further production waste; X – Should any sanitary problems be identi- III – to establish procedures for the disinfec- fied, the poultry litter shall be subjected to a fer- tion of vehicles at the poultry establishment en- menting process for at least 10 days before its re- trance and exit; moval from the shed or another method approved IV – the poultry establishment personnel is by the Animal Health Department that assures the to wear clean clothes and shoes; inactivation of disease agents. Commercial broiler 183 V – to adopt adequate procedures for the establishments shall assure that poultry litter shall destination of wastewater and production waste be re-used only if there is no sanitary problem de- (dead birds, discarded eggs, manure and pack- tected that may represent any potential risk to the ages), according to the environmental legislation next lot to be housed, to the national poultry flock in force; and to public health, according to the clinical in- VI – to prepare and execute a cleaning and spection by the establishment’s technical person in disinfection programme to be carried out in the charge or by the official veterinarian or even during sheds after the exit of each lot of birds; the slaughter of the lot by the Animal Origin Prod- VII – to keep registers of the pest control pro- ucts Inspection Service. gramme so as to keep the sheds and feed or egg Art. 22. At Commercial and Poultry Breeding storage rooms free from insects and rodents, wild Establishments, there will be sanitary monitoring animals or domestic pets; for Newcastle disease, avian influenza, Salmonel- VIII – to carry out physical, chemical and losis, Mycoplasmosis, and the use of veterinarian bacteriological analyses of the water according drugs and environmental contaminants, accord- to the norms established in CONAMA Resolution ing to the respective specific procedures. No. 357 of March 17, 2005, except for the count Paragraph 1. Other diseases may be included of thermotolerant coliforms, which shall follow in the monitoring system at the discretion of the the norm established by the Ministry of Health Ministry of Agriculture, Livestock and Food Supply. Paragraph 2. The sanitary monitoring pro- birds shall be free of the pathogenic agents grammes shall vary in consideration to the dif- and specific antibodies for the following mi- fering purposes of the establishments, according croorganisms: to the classification described in Articles 3 and 4 I - Avian Adenovirus (Groups I, II and III); of this attachment. II - Chicken Infection Anemia; Paragraph 3. The official service veterinar- III - Haemophilus paragallinarum ian is responsible for the inspection and supervi- (Avibacterium paragallinarum); sion of sanitary monitoring activities, by making IV - Mycoplasma gallisepticum and inspection visits and through documentation M. synoviae; follow up. V - Avian Paramyxovirus (types II and III); Paragraph 4. The veterinarian in charge shall VI - Avian pneumovirus; be responsible for the execution of hygiene-san- VII - Avian reovirus; itary controls of Commercial and Poultry Breed- VIII - Salmonella pullorum, S. gallinarum, ing Establishment flocks. S. enteritidis Paragraph 5. Commercial and Poultry IX - Salmonella sp.; Breeding Establishments shall keep a register X - Avipoxvirus; of sanitary monitoring procedures for each bird XI - Coronavirus infectious bronchitis virus; lot or hatchable egg lot, with reference to the XII - Marek’s Disease Virus; diseases contemplated in the National Poultry XIII - Newcastle Disease Virus; Health Plan. XIV - Gumboro Disease Virus; Paragraph 6. These tests shall be obligatorily XV - Avian Encephalomyelitis Virus; carried out at laboratories belonging to the na- XVI - Avian Influenza Virus; tional network of agricultural and livestock labo- XVII - Avian Infectious Laryngotracheitis ratories of the Agriculture and Livestock Health Virus; Care Unified System. XVIII - Avian Leukosis Virus; and Paragraph 7. Commercial and Poultry Breed- XIX - Reticuloendotheliosis Virus. ing Establishments shall establish procedures to as- Paragraph 1. Lots of birds producing SPF sure the traceability of animals and hatchable eggs. eggs shall be monitored according to the specifi- Art. 23. The lots of SPF egg producing cations in the following table: 184 AGENT TEST INTERVAL ABBREVIATIONS LOT /% Avian Adenovirus group I – AGID; VN (4) (5) Tests and abbreviations – Serotypes 1-12 Avian Adenovirus group II (HEV) AGID (4) AGID - Agar gel immunodifusion test Avian Adenovirus group III (EDS-76) HI; AGID (4) (5) VN – Virus Neutralisation Avian Encephalomyelitis Virus ELISA; AGID; VN (4) (5) HI - Hemagglutination Inhibition Avian Reovirus AGID; VN; ELISA (4) (5) ELISA - Enzyme Linked Immunosorbent Coronavirus infectious bronchitis AGID; ELISA (2) (5) Assay virus CO - Clinical observation Gumboro Disease Virus ELISA; AGID; VN (2) (5) Newcastle Disease Virus HI; ELISA (2) (5) PAT - Plate Agglutination Test Avian Influenza Virus (type A) AGID (2) (5) AI – Agent isolation Avian Leukosis Virus A, B VN; ELISA (4) DVE – Duck virus enteritis Lymphoid Leukosis Virus A, B, C, D ELISA (2) EDS - Egg Drop Syndrome and J Marek’s Disease Virus – Serotypes 1, 2 AGID (2) (5) Frequency and percentage of birds and 3 tested Reticuloendotheliosis Virus ELISA; AGID (2) (5) (1) At the beginning of egg-laying – Avipoxvirus AGID; CO (4) 100% of the lot; Avian Infectious Laryngotracheitis ELISA; AGID (4) Virus (2) Upon the first sampling - 10% of the Mycoplasma synoviae PAT; HI; AI (2) (5) lot and in following months: - 5% of Mycoplasma gallisepticum PAT; HI; AI (2) (5) the lot; Avian pneumovirus ELISA; VN (2) Avian paramyxovirus – Types II and III HI (2) (4) (3) Up to 5 days old – Observation of Salmonella Pullorum / S. Gallinarum PAT; AI (1); (3) (4) Mortality – submission for serological 185 test; Salmonella Enteritidis PAT; ELISA ; AI (3); (4) Salmonella sp. AI (3); (4) (4) Monthly – 60 birds; Haemophilus paragallinarum (Avibac- CO - terium paragallinarum) (5) Weekly – 40 birds. Chicken Anaemia Virus ELISA; VN (1); (2)

Paragraph 2. The tests shall be carried out ed in the monitoring system at the discretion of at the national network of agricultural and live- the Ministry of Agriculture, Livestock and Food stock laboratories of the Agriculture and Livestock Supply. Health Care Unified System, and their registries shall be kept stored and available to inspection Art. 24. With regard to the sanitary control for a minimum period of 3 years. of controlled egg producing birds for the produc- Paragraph 3. The supply of SPF eggs for tion of inactivated vaccines, the following stan- trading and incubation shall be suspended dur- dard shall be obeyed: ing the positive diagnosis period for the diseases I – Chicken lots must be clear of pathogenic mentioned in this article. agents and antibodies specified for the following Paragraph 4. Other diseases may be includ- microorganisms: a) Avian Adenovirus group III (EDS 76), when the following agents: not vaccinated; a) Avian Anemia Virus; b) Mycoplasma gallisepticum, M.synoviae; b) Haemophilus paragallinarum (Avibacte- c) Salmonella gallinarum, S. pullorum, S. en- rium paragallinarum); teritidis and S. typhimurium. c) Avian pneumovirus; d) Avian Influenza Virus; d) Avian Reovirus; e) Avian Infectious Laryngotracheitis Virus; e) Avipoxvirus; f) Avian Leukosis Virus; and f) Avian Infectious Bronchitis Virus; g) Reticuloendotheliosis Virus. g) Marek’s Disease Virus; II – Lots of birds producers of Anseriformes h) Newcastle Disease Virus; eggs controlled for the production of inactivated i) Gumboro Disease Virus; and vaccines must be clear of the following patho- j) Avian Encephalomyelitis Virus. genic agents and antibodies: IV – Lots producing Anseriformes eggs con- a) Avian Adenovirus group III (EDS 76) – vac- trolled for the production of inactivated vaccines cination not allowed; must be clear of clinical manifestations of infec- b) Mycoplasma gallisepticum, M.synoviae; tions caused by the pathogenic agents specified c) Salmonella gallinarum, S. pullorum, S. en- in this Article’s caput as well as the following: teritidis and S. typhimurium. a) Duck Enteritis Virus; d) Newcastle Disease Virus; b) Duck Hepatitis Virus; and e) Duck Enteritis Virus; c) Eastern Equine Encephalomyelitis Virus. f) Duck Hepatitis Virus; e V – Lots of birds producing eggs controlled g) Avian Influenza Virus. for the production of inactivated vaccines shall III – Lots of controlled layers for the produc- be monitored every 30 (thirty) days. The diagno- tion of inactivated vaccines must be clear from sis tests specified in the following table must be clinical manifestations of infections caused by carried out on at least 30 (thirty) birds:

AGENT TEST(*) TESTS AND ABBREVIATIONS Avian Adenovirus group III (EDS-76) AGID; HI AGID - Agar gel immunediffusion test Avian Influenza Virus AGID; ELISA HI - Hemagglutionation Inhibition 186 Mycoplasma synoviae PAT; HI; AI ELISA - Enzyme Linked Immunosorbent Assay Mycoplasma gallisepticum PAT; HI; AI PAT - Plate Agglutination Test Salmonella Pullorum/S. Gallinarum PAT; AI AI– Agent isolation AI* - agent isolation from cloacae swab Salmonella Enteritidis PAT; ELISA; AI EDS - Egg Drop Syndrome Mycoplasma gallisepticum; Salmonella Typhimurium AI Mycoplasma synoviae; Salmonella enteritidis; Salmonella Salmonella sp. AI* typhimurium; Salmonella pullorum and Salmonella Avian Infectious Laryngotracheitis ELISA; AGID gallinarum, shall follow the same model required for the Virus control of reproducing birds, but at 30 days intervals in Avian Leukosis Virus A, B VN; ELISA between each monitoring. Reticuloendotheliosis Virus ELISA; AGID

Paragraph 1. The supply of controlled eggs work of agricultural and livestock laboratories of for the production of inactivated vaccines shall be the Unified Agriculture and Livestock Health Care suspended during the period of clinical manifes- Unified System, and their registers shall be kept tation of the diseases mentioned in this article. stored and available for inspection for a mini- Paragraph 2. The tests shall be carried out mum period of 3 (three) years. by laboratories that are part of the national net- Paragraph 3. The production of antigens in controlled Anseriformes eggs must always be dures established by the Ministry of Agriculture, made in isolation and the eggs may not be sent Livestock and Food Supply, all poultry establish- to hatchery together with other controlled or SPF ments in international trade must follow the re- eggs within the production laboratory. quirements of the importing countries. Paragraph 4. Every imported avian vaccine Paragraph 2. In order to issue the Animal produced in isolation or combination in con- Movement Permit for birds, the qualified vet- trolled eggs shall have their importation sus- erinarian must also be the technical person in pended upon the occurrence of an exotic avian charge for the establishment of origin. disease in Brazil or a disease listed by the OIE un- Art. 27. The vaccination of breeding and til the country is considered free of such disease commercial poultry flocks may only be carried by the Brazilian Official Veterinary Service. out with a vaccine duly registered with the Minis- Paragraph 5. Every imported avian vaccine try of Agriculture, Livestock and Food Supply. produced in isolation or combination in controlled Paragraph 1. The vaccination programme shall eggs shall be accompanied by an expert report be specific per region and productive segment. contemplating the tests required by the Ministry Paragraph 2. Breeding birds – with the ex- of Agriculture, Livestock and Food Supply. ception of SPF birds – commercial layers and or- Paragraph 6. Other diseases may be included namental birds shall be systematically vaccinated in the monitoring system at the discretion of the against Newcastle disease. Ministry of Agriculture, Livestock and Food Supply. Paragraph 3. Broiler establishments vacci- Art. 25. At poultry breeding establishments, nating against Newcastle disease and other offi- the eggs must be collected at frequent intervals cially controlled diseases shall obligatorily inform in cleaned and disinfected recipients. the activity to the state animal health and inspec- Paragraph 1. After being collected, clean eggs tion service. must be disinfected as soon as possible, stored Paragraph 4. In case of an exotic disease, sys- at a specific location and kept at a temperature tematic vaccination shall not be allowed. between 13 and 25o C and a relative air humidity Paragraph 5. At Breeding Hatchery Estab- between 70 and 85%. lishments there shall be obligatory vaccination Paragraph 2. Dirty, broken or cracked eggs against Marek’s disease before the dispatch of must be collected at separate recipients and may day-old birds. 187 not be destined for incubation. Paragraph 3. The eggs must be dispatched di- CHAPTER IV rectly from the farm’s stock room to the hatchery. Paragraph 4. The eggs must be transported FINAL PROVISIONS in appropriate closed vehicles: on trays, trolleys and boxes kept in good state of conservation and Art. 28. Poultry establishments shall allow the disinfected prior to each shipment. The boxes official veterinarian to access the documents and and trays, if made of carton, must be first use. premises, all biosecurity procedures observed. Paragraph 5. Day old birds must be dis- Art. 29. The veterinarians qualified to issue patched directly from the hatchery to the place Animal Movement Permits from registered poul- of destination. try establishments, who observe birds displaying Paragraph 6. The transporting vehicle must be sudden and quantitatively increased signs outside cleaned and disinfected prior to each shipment. normal production standards, such as the decrease Art. 26. The interstate transit of birds, in- in egg production, in water or feed consumption, cluding those destined for slaughter, as well as and increased mortality rate occurring within a manure and poultry litter, shall comply with the 72-hour period shall communicate the fact im- regulations provided for in this article. mediately and officially to the animal health and Paragraph 1. As well as following the proce- inspection service of the federation unit. ATTACHMENT II POULTRY ESTABLISHMENTS REGISTRATION FORM

1. Establishment General Information Taxpayer’s No. (TAXPAYER’S No. State Registration No. Or Producer Registration (CNPJ/CPF)): Incra No.: Individual (1) Legal Entity (2) Company Name: Brand or Trade Name:

2. Establishment Location Address – street name: District: Location: Municipal Area: Postal Code: Federation Unit:

3. Mail Address

Address - street name: District: Location: Municipal Area: Postal Code: Federation Unit: Telephone: Fax: Post Box: E-mail:

4. Establishment’s Area of Performance

Area: Activity: Classification: Additional Characteristic: 188 Activity: Classification: Additional Characteristic: Activity: Classification: Additional Characteristic:

5. Cooperative / Integrator (in case the activity is integrated or cooperate)

Taxpayer’s No. (CNPJ/CPF): Company Name: Trade Name: Address - street name: Municipal Area: Federation Unit: Registration Date: ____/____/____

6. Technical Person in Charge

Name: Profession: VETERINARY DOCTOR Taxpayer No. (CPF): Abbreviation: CRMV Region (Federation Unit): Registration No.: Type of responsibility: 1 Type of Technician: (1 – title holder / 2 – substitute) 7. Type of Property Owned Leased (if leased, please fill below) Name of owner: Taxpayer’s No. (CPF/CNPJ): Address:

8. Location / Premises DATUM: South American 69 (SAD69) GPS Coordinates (decimal format) S: W: Property Area: (ha) Area used for poultry breeding: (ha) No. of Nuclei: No. of Sheds / Paddocks: Constructed Area: Housing Capacity: No. of persons involved with the activity:

9. Person Responsible for the Information Name: Title: Identity Document:

10. Declaration

I do so declare that all the information given in this form is true and any change to such information shall be communicated immediately to the animal health and inspection body.

Place and date:

Signature

11. Person Responsible for the Registration To be filled by the employee responsible for the local veterinary attention unit 189 Name: Body: Title: Employee No:

Filling of item 4 of Registration Form Parent Farm Area of Interest: SPF controlled egg Farm Animal Multiplication Material (breeding) Pure Line Hatchery Commercial Birds Great-grandparent Hatchery Activity: Grandparent Hatchery Independent Producer Parent Hatchery Integrated Producer Ostrich Hatchery Cooperate Producer Ostrich Farm - Breeding Classification: Ostrich Farm – Breeding and Fattening Breeding Birds Ostrich Farm - Fattening Pure Line Farm Ostrich Farm – Complete Cycle Great-grandparent Farm Ostrich Farm – Partial Cycle Grandparent Farm Parent Raising Farm up to 20 weeks old Chick Raising Farm from day-old to 20 weeks Turkey - egg-laying old Teals – meat poultry Commercial Birds: Teals - egg-laying Broiler Farm Commercial Birds Egg Farm Chicken Other production bird and ornamental bird Turkey Farm Duck Additional Characteristics (species): Teal Breeding Birds Quail Chicken – meat poultry Helmeted Guinea fowl Chicken – egg-laying Ostrich Duck – meat poultry Rhea Duck - egg-laying Others (please specify) Turkey – meat poultry

ATTACHMENT III

POULTRY ESTABLISHMENT REGISTRATION FORM

To the Federal Superintendence of Agriculture of the State of ______, (Legal Entity or Individual) Taxpayer’s No. (CNPJ/ CPF)______, located at ______(Full address) ______, GPS Coordinates (decimal format SAD 69) S: ______; W: ______, District ______, Municipal Area ______State ______Postal Code ______,Telephone______, fax ______, Post Box 190 No.______,e-mail______. Requests its registration with the Federal Superintendence of Agriculture as ______In accordance with Normative Instruction of the Ministry of Agriculture, Livestock and Food Sup- ply establishing the PROCEDURES FOR THE REGISTRATION, INSPECTION AND CONTROL OF POULTRY BREEDING ESTABLISHMENTS, all documents required by the legislation in force are attached to the present document. RESPECTFULLY SUBMITTED,

______, ______, ______.

______

(signature of the owner or legal representative) ATTACHMENT IIIA

POULTRY ESTABLISHMENT REGISTRATION REQUEST

To the Animal Health and Inspection Body of the State of ______. ______, (Legal Entity or Individual) Taxpayer’s No. (CNPJ/CPF) ______, located at ______(Full address) ______GPS Coordinates (decimal format SAD 69) S: ______; W: ______, District ______, Municipal Area ______State ______Postal Code ______, Telephone______, fax ______, Post Box No.______,e-mail______. requests its registration with this Animal Health and Inspection Body as ______In accordance with Normative Instruction of the Ministry of Agriculture, Livestock and Food Supply establishing the PROCEDURES FOR THE REGISTRA- TION, INSPECTION AND CONTROL OF POULTRY BREEDING ESTABLISHMENTS, all documents required by the legislation in force.

RESPECTFULLY SUBMITTED,

______, ______, ______. ______(signature of the owner or legal representative) 191

ATTACHMENT IV

PHYSICAL AND HEALTH INSPECTION TECHNICAL REPORT - MINIMAL GUIDE

OWNER: ESTABLISHMENT: LOCATION: TYPE OF EXPLOITATION: REGISTRATION PROCESS NO.: The establishment has been inspected according to the provisions of the Ministry of Agriculture, Livestock and Food Sup- ply Normative Instruction establishing the PROCEDURES FOR THE REGISTRATION, INSPECTION AND CONTROL OF POULTRY BREEDING ESTABLISHMENTS.

Sequence Item Present Regular Absent Documents 1 Legal Existence Documents 2 Technical Person in Charge (contract + Veterinarian Medicine Council card) 3 Situation Plant or Aerial Survey Floor plan 4 Environmental Body Protocol or Surety 5 Specifications List Structure: 6 Regulated Distances 7 Materials Used (cleaning and disinfection) Internal premises required 8 Screen (except SPF, Pure Line and Great-grandparent) 9 Isolation fence with single access 10 Movement Control Registration (vehicles and persons) 11 Disinfection of Vehicles 12 Pest Control 192 13 Microbiological Analysis of Water 14 Management Registration

Is apt / inapt to obtain registration with this Federal Superintendence of Agriculture, Livestock and Food Supply of the State of______. Notes______

Signature and stamp Signature and stamp FFA – SEDESA Head of SEDESA of the Federal Signature and stamp Superintendence of Agriculture-XX FFA – SEFAG Signature and stamp Head of SEFAG of the Federal Superintendence of Agriculture-XX

THIS INSPECTION TECHNICAL REPORT IS VALID FOR ONE YEAR, CONDITIONED TO THE MAINTENANCE OF THE SANITARY STATUS OF THE NUCLEI OR POULTRY ESTABLISHMENT. ATTACHMENT IV-A

PHYSICAL AND HEALTH INSPECTION TECHNICAL REPORT - MINIMAL GUIDE

OWNER: ESTABLISHMENT: LOCATION: TYPE OF EXPLOITATION: REGISTRATION PROCESS No.: The establishment has been inspected according to the provisions of the Ministry of Agriculture, Livestock and Food Sup- ply Normative Instruction establishing the PROCEDURES FOR THE REGISTRATION, INSPECTION AND CONTROL OF POULTRY BREEDING ESTABLISHMENTS.

Sequence Item Present Regular Absent Documents 1 Legal Existence Documents 2 Technical Person in Charge (contract + Veterinarian Medicine Council card) 3 Sketch or Aerial Survey 4 Environmental Body Protocol or Surety 5 Specifications List Structure 6 Regulated Distances 7 Materials Used (cleaning and disinfection) 8 Screen 9 Good Production Practices 10 Isolation fence with single access 11 Movement Control Registration (vehicles and persons) 12 Disinfection of Vehicles 13 Pest Control 14 Microbiological Analysis of Water 193 15 Management Registration

Is apt / inapt to obtain registration with this Federal Superintendence of Agriculture, Livestock and Supply of the State of______. Notes______.

Signature and stamp Signature and stamp Official responsible for the inspection VETERINARY DOCTOR Head of the State Animal Health Service

THIS INSPECTION TECHNICAL REPORT IS VALID FOR ONE YEAR, CONDITIONED TO THE MAINTENANCE OF THE SANITARY STATUS OF THE NUCLEI OR POULTRY ESTABLISHMENT. ATTACHMENT V

POULTRY ESTABLISHMENT REGISTRATION CERTIFICATE

Classification ______Proceeding No. ______Registration No. ______We hereby certify that, in accordance with the Normative In- struction of Ministry of Agriculture, Livestock and Food Supply, establishing the PROCEDURES FOR THE REGISTRATION, INSPECTION AND CONTROL OF COMMERCIAL AND POULTRY BREEDING ESTAB- LISHMENTS, the poultry establishment:______Owner / Company______Taxpayer No. (CPF / CGC) ______Located at ______GPS Coordinates - S: ______; W: ______, Municipal Area ______State ______Is registered for the production of ______Valid until ______/ ______/ ______.

______, ______, ______.

______Person Responsible for Issuing the Registration BODY ISSUING THE REGISTRATION

NORMATIVE INSTRUCTION No. 17 OF APRIL 7, 2006.

194 Published in the Official Gazette of April 10, 2006 Section 1, Page 06

Approves within the scope of the National Avian Health Program, the National Plan for the Prevention of Avian Influenza and Control and Prevention of Newcastle Disease

THE SECRETARY OF ANIMAL AND PLANT No. 21000.001074/2006-37, hereby resolves: HEALTH AND INSPECTION OF THE MINISTRY OF Art. 1. To approve, within the scope of the AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, in National Avian Health Program, the National accordance with the duties and responsibilities Plan for the Prevention of Avian Influenza and assigned thereto by Articles 9 and 42, Annex I, De- Control and Prevention of Newcastle Disease all cree No. 5,351 of January 21, 2005, and in com- over the national territory, as provided for in the pliance with the provisions of Ministerial Admin- Annex to this Normative Instruction. istrative Ruling No. 193 of September 19, 1994, Art. 2. This Normative Instruction shall enter as well as the contents of the Judicial Proceeding into force on the date of publication thereof.

GABRIEL ALVES MACIEL ANNEX

NATIONAL PLAN FOR THE PREVENTION OF AVIAN INFLUENZA AND CONTROL AND PREVENTION OF NEWCASTLE DISEASE

Art. 1. The National Plan for the Prevention the National Plan for the Prevention of Avian In- of Avian Influenza and Control and Prevention of fluenza and Control and Prevention of Newcastle Newcastle Disease is a strategy feasible of being Disease: adopted in all Units of the Federation (UF) to pro- I – Animal and Plant Health and Inspection mote actions focused on animal sanitary health Secretariat: and inspection, with a view to strengthening the a) Animal Health Department - DSA; veterinary care system and implementing the Na- b) Department of Inspection of Animal Ori- tional Avian Health Program (PNSA) all over the gin Products - DIPOA; national territory. c) Department of Surveillance of Livestock Art. 2. Acceptance of the rules provided for Inputs - DFIP; in the plan by the UFs is voluntary. The criteria c) General Coordination of Laboratory Sup- described herein will serve to review the local port - CGAL; veterinary care systems and consequently to rank d) Coordination of the International Agricul- the UFs by sanitary status in relation to Avian In- ture and Livestock Surveillance System - VIGIAGRO; fluenza and Newcastle Disease. II – Federal Agriculture Superintendencies Art. 3. For the purpose of implementing the - SFA; National Plan for the Prevention of Avian Influenza III – State Agriculture Secretariats and Ani- and Control and Prevention of Newcastle Disease mal Sanitary Health and Inspection Agencies and making it operational and based on geopoliti- thereof; and cal criteria, Brazil will be divided into regions. IV – The private sector. Paragraph 1. The Animal Health Department Paragraph 1. the DSA shall: (DSA) will carry out periodic audits according to I –Coordinate actions aimed at determining the criteria set forth in complementary rules, in the epidemiological situation in the region with those UFs that have joined the plan, so as to con- regard to Avian Influenza and Newcastle Disease firm the implementation of the rules provided in Brazil, by performing annual epidemiological 195 for in the National Plan for the Prevention of inquiries; Avian Influenza and Control and Prevention of II – Maintain updated the legal framework Newcastle Disease and the suitability of animal of actions to combat Avian Influenza and New- sanitary health and inspection services. castle Disease as well as the PNSA action manuals Paragraph 2. The UFs may join the plan sepa- relating to operational procedures and field and rately by forming regional blocs of UFs or by de- sanitary emergency activities; marcating internal areas in their territories, as long III – Define the parameters of sanitary status as they are capable of providing equivalent guaran- and efficiency levels equivalence in the execution ties that the animal sanitary health and inspection of activities pertaining to animal sanitary health system will be operational in the proposed area. and inspection services, related to the National Art. 4. The DSA will continually review and Plan for the Prevention of Avian Influenza and regulate the PNSA manuals as regards both routine Control and Prevention of Newcastle Disease; and sanitary emergency activities related to Avian IV – Provide sample educational material Influenza and Newcastle Disease and adjustment with a view to promoting uniform actions as proof the rules to different poultry sectors such as vided for in the PNSA, in the national territory breeding, slaughter, commercial egg-laying, ratite, and at all levels of execution; ornamental and non-commercial aviculture. V – Publish specific interstate movement rules Art. 5. The following sectors will take part in for the different types of aviculture activities, aimed at meeting the requirements for implementing the LANAGRO, quick and affirmative diagnoses for National Plan for the Prevention of Avian Influenza Avian Influenza and Newcastle Disease, by mod- and Control and Prevention of Newcastle Disease; ernizing the equipment used and training the VI – Permanently update the sanitary re- technical staff responsible for performing the quirements regarding the importing and export- tests, with a view to carrying out annual serologi- ing of live birds, genetic material, poultry prod- cal monitoring as requested by the DSA. ucts and byproducts, with a view to complying Paragraph 5. VIGIAGRO shall: with the rules provided for in the National Plan I – Coordinate the inspection, in all Agricul- for the Prevention of Avian Influenza and Control ture and Livestock Surveillance Units at the points and Prevention of Newcastle Disease; of entry into the country, of imports of: live birds VII – Introduce changes into biosafety and and edible and inedible products and byprod- hygienic-sanitary measures for the prevention of ucts thereof; eggs and edible and inedible prod- Avian Influenza and Newcastle Disease in domes- ucts and byproducts thereof; hatching eggs and tic bird breeding establishments; bird semen, or any other material for the animal VIII – Maintain updated the national register breeding of birds; biological poultry products; of veterinarians accredited for issuing the Animal II – Ensure that the above mentioned prod- Movement Permit (GTA) for birds; ucts, when originating in or in transit through IX – Establish sanitary rules for participation countries considered as risk zones by the DAS, in agriculture and livestock events. will be subject to previous importing and inter- Paragraph 2. the DIPOA shall: ception authorization and prohibition of entry or I – Immediately notify the DSA of the inci- destruction; dence of mortality rates above 10% in batches of III – Ensure the inspection of solid waste from slaughter birds occurred within less than seventy air, sea and land transportation vehicles, by requir- two (72) hours and recorded in the sanitary re- ing that such waste be treated in primary areas port as provided for in Administrative Ruling SDA through methods of proven scientific efficacy and No. 210 of November 10, 1998, Annex IV; prohibiting the entry into the national territory of II - Immediately notify the DSA of the iden- materials that are potential carriers of diseases; tification of signs typical of Avian Influenza or IV – Ensure inspection of hand luggage and/ Newcastle Disease, during the ante-mortem in- or checked-in luggage in international passenger spection of the batch; landing terminals at international airports, fron- 196 III – Participate in the active surveillance for tier posts, sea and river ports, by confiscating and Avian Influenza and Newcastle Disease by collect- destroying agricultural and livestock products ing biological samples in slaughterhouses during that are not accompanied with the appropriate inspection of the birds. import authorization or certification; Paragraph 3. the DFIP shall: V – Promote the enhancement of sanitary I – Keep control of vaccines by UF, with re- education campaigns aimed at international inspect to the amount produced or imported by a transit passengers. laboratory and the amount used; Paragraph 6 . The SFA shall: II – Evaluate the vaccines and drugs avail- I – Ensure, at state level, adoption of the able and record them at the DAS’s request. routine and emergency measures provided for Paragraph 4. The CGAL shall: in the legislation in force and in the Contingency I – Ensure the supply of laboratory diagnosis Manual in case of suspicion of Avian Influenza or as requested by the DSA, so as to contribute to Newcastle Disease; the annual epidemiological monitoring of bird II – Accredit veterinarians to issue GTA for the flocks as well as of the active and passive sur- interstate movement of birds; veillance processes for Avian Influenza and New- III – Keep an updated register of veterinar- castle Disease; ians accredited to issue GTA; II – Develop, in the laboratory network of IV – Carry out educational actions pursuant to the rules and other sources designated by the DSA; IV – Participate in the State Poultry Health V – Participate in the State Poultry Health Committee and in the actions of the State Groups Committee and in the actions of the Groups on on Sanitary Emergency in Poultry Health; Sanitary Emergency in State Poultry Health; V – Take the minimum biosecurity actions VI – Update the georeferenced register, in defined by the PNSA in commercial poultry es- electronic format, of all poultry breeding estab- tablishments. lishments and producers of specific pathogen- Art. 6 . The states that join the National Plan for free (SPF) or controlled eggs. the Prevention of Avian Influenza and Control and Paragraph 7. State Animal Sanitary Health Prevention of Newcastle Disease should establish, by and Inspection Agencies in the UFs joining the legal act, the State Poultry Health Committee, com- plan shall: prised of representatives of the SFA, the State Animal I – Ensure operation of the veterinary care Sanitary Health and Inspection Committee, private and sanitary surveillance in poultry health system, entities representing the poultry sector, and the sci- so as to enable implementation of the PNSA; entific community, with a view to proposing actions II – Adjust specific state legislation to poultry to the DSA, based on each state’s reality. health by making sure that it is in tune with the Art. 7. The DSA shall organize, on an annual federal legislation and taking into account sani- basis as a minimum, an active surveillance study tary emergency actions; on Avian Influenza and Newcastle Disease. III – Carry out educational actions pursuant to Paragraph 1. The study shall cover the UFs the rules and other sources designated by the DSA; with a continuously updated georeferenced reg- IV – Develop and promote permanent train- ister in electronic format in the DSA’s Poultry ing for Sanitary Emergency Groups, pursuant to Health Coordination Unit (CSA). the DSA regulation; Paragraph 2. The sampled population will V – Participate in the State Poultry Health include: commercial slaughter fowls; commer- Committee as well as in the actions of the Sate cial laying fowls; non-commercial domestic Groups on Sanitary Emergency in Poultry Health; fowls; and migratory birds. VI – Update the georeferenced register, in Art. 8. The DSA shall certify establishments electronic format, of all commercial poultry estab- that are free of Avian Influenza and Newcastle lishments and migratory winter sites for migrato- Disease. ry birds. The following should also be located and Sole Paragraph. The certification referred to 197 identified by georeferencing: zoos, slaughterhous- in the heading of this Article shall cover poultry es and carcass processing plants and commercial breeding establishments and producers of SPF or establishments selling live birds. controlled eggs. Paragraph 8. The private sector shall: Art. 9. The CGAL shall be responsible for ac- I – Immediately notify the Official Service of crediting public laboratories for the serological di- any suspect case of Avian Influenza or Newcastle agnosis of Avian Influenza and Newcastle Disease Disease and take the actions required for the full in each of the UFs that has the conditions required investigation of the situation; for executing the plan, providing passive surveil- II – Foster the development of private state lance and establishment certification programs. funds recognized by the Ministry of Agriculture, Art. 10. The SFAs shall provide the DSA with Livestock and Food Supply (MAPA), for the pur- the list of veterinarians accredited to issue GTAs pose of carrying out emergency actions in case and the list of establishments certified in the of Avian Influenza or Newcastle Disease foci in PNSA sanitary programs. commercial or non-commercial flocks, including Paragraph 1. The CSA shall publish the list of the possibility of awarding compensation; veterinarians accredited to issue GTAs and the list III – Promote continued education programs of establishments certified in the PNSA sanitary for veterinarians, technical staff and producers of programs, to be posted on the MAPA website and poultry, as provided for in the PNSA manuals; updated on a monthly basis. Paragraph 2. The SFAs shall submit to the tion Certificate (CIS) shall be issued by the official CSA, up to the 5th working day of each month, veterinarian or the veterinarian accredited by the changes introduced into the lists referred to MAPA, technically responsible for the establish- in paragraph 1 of this Article. ment of origin of the birds and hatching eggs, as Art. 11. Interstate transit for different types regards the items described in § 1 of this Article. of exploitation of live birds, genetic material, ed- Paragraph 3. Starting on the date to be de- ible and inedible products and byproducts shall fined by the DSA, the interstate transit of birds comply with the following rules: and hatching eggs as referred to in items I, II, III, Paragraph 1. The interstate transit of fowl IV, V, VI, VII, VIII and IX, § 1 of this Article, will only and hatching eggs described in items I, II, III, IV, be permitted if the establishment of origin of the V, VI, VII, VIII and IX of this paragraph shall be au- material is certified as free of Avian Influenza and thorized, provided that the specimens originate Newcastle Disease. in establishments certified as free of Mycoplasma Paragraph 4. Starting on the date to be de- and Salmonella, according to Normative Instruc- fined by the DSA, the CIS for the interstate transit tion SDA No. 44, of August 23, 2001, and Norma- of clear eggs as referred to in item VIII, § 1 of this tive Instruction SDA No. 78, of November 3, 2003, Article, will only be permitted if the establish- and in the case ratite, Joint Normative Instruction ment of origin of the material is certified as free SDA/SARC No. 02, of February 21, 2003. of Avian Influenza and Newcastle Disease. I – genetic selection farms of primary breed- Paragraph 5. The interstate transit of slaugh- ing flocks (pure lines), importers, exporters, pro- ter fowl shall be accompanied with the GTA is- ducers of hatching eggs and day-old birds for the sued by an official veterinarian or a veterinarian production of “great-grandmother” hens; accredited by MAPA, technically responsible for II – farms that import and export great- the establishment of origin of the birds. grandmother hens, produce hatching eggs and Paragraph 6. The interstate transit of spent day-old birds for the production of breeding fowl from breeding farms and of spent fowl from grandmother hens; farms producing eggs for consumption shall be III – farms that import and export grand- accompanied with the GTA issued by an official mother hens, produce hatching eggs and day-old veterinarian. These birds shall be sent to slaugh- birds for the production of parent breeders; ter plants under federal inspection. Issuing of the IV – farms that import and export parent GTA shall be linked to the proof of receipt, by the 198 breeders, produce hatching eggs and day-old birds SIF, of previously sent spent fowl batches. for the production of commercial fowl, parent Paragraph 7 . Those UFs that join the National breeders up to 24-week old and other purposes; Plan for the Prevention of Avian Influenza and Con- V – establishments that produce commercial trol and Prevention of Newcastle Disease and dem- laying hens (90-day old); onstrate operational capacity to fulfill all of the VI - establishments that exploit other bird PNSA rules may, as a preventive measure against species, whether ornamental or not, intended the possible entry and dissemination of Avian for the commercial production of meat, eggs or Influenza and Newcastle Disease agents in their feathers, such as turkey, quail, Guinea fowl, os- flocks, prohibit the interstate transit of slaughter trich, Brazilian ostrich, emus; fowl, spent fowl from breeding farms and spent VII – commercial breeding of ostrich and fowl from consumption egg farms intended for Brazilian ostrich, with the production of hatching slaughter, and shall comply with the following: eggs and young no more than 90-day old; I – for the interdiction of the interstate transit VIII – clear eggs (hatchery eggs) intended for of slaughter fowl, spent fowl from breeding farms, industrial use; and spent fowl from consumption egg farms in- IX – establishments controlled or free of spe- tended for slaughter, the UF shall submit before- cific pathogens. hand to the approval of the DSA, the operational Paragraph 2 . The GTA or the Sanitary Inspec- and inspection plan relating to this activity; II – transit restriction shall only be valid to representative of the batch, that prove negative those UFs with a differentiated sanitary status or for Avian Influenza and whose parameters shall differentiated levels of efficiency in the execution be defined by the DSA. The results of the serologi- of activities related to animal sanitary health and cal tests shall be valid for seven (7) days. inspection services, as provided for in Art. 5, § 1, Art. 12. The participation of birds, including item III of this Normative Instruction. ratite, in agriculture and livestock events such as Paragraph 8 . The interstate transit of ma- fairs, exhibits, auctions and other animal con- nure and aviary bed, as well as of waste from centrations shall be authorized only when the hatcheries and slaughterhouses, regardless of birds originate in establishments certified as free the purpose, is hereby prohibited. This restriction of Mycoplasma and Salmonella, as provided for excludes materials that have been submitted to in SDA No. 44, of August 23, 2001, and Norma- treatment approved by the SDA, capable of en- tive Instruction SDA No. 78, of November 3, 2003, suring the elimination of disease-causing agents. and in the case ratite, Joint Normative Instruction I – The interstate transit of these materials shall SDA/SARC No. 02, of February 21, 2003. be accompanied with a CIS specifying the treatment Paragraph 1. The participation of passerine to which the material has been submitted, issued ornamental birds, whether alien to the domestic by the Veterinarian Accredited by the SFA. fauna or not, in agriculture and livestock events, Paragraph 9. Where official surveillance shall only be permitted when the birds are ac- programs identify the presence of the high companied with a GTA issued by an official vet- pathogenicity form of the Avian Influenza virus erinarian and by a sanitary inspection certificate or of Newcastle Disease, the following interstate issued by a veterinarian, without prejudice to transit control measures shall be immediately other legal requirements. adopted and remain in force until completion Paragraph 2. Starting on a date to be defined of the outbreak sanitation activities provided by the DSA, the participation of birds, including for in the Contingency Manual for Avian Influ- ratite, in agriculture and livestock events shall enza and Newcastle Disease: only be authorized for those birds originating in I – day-old birds and eggs originating in the breeding establishments certified as free of Avian establishments described in items I, II, III, IV and Influenza and Newcastle Disease. IX, § 1 of this Article shall be accompanied with a Paragraph 3. Until the date to be defined GTA issued by an official or accredited veterinari- by the DSA, the participation in agriculture and 199 an, following the performance of serological tests livestock events of birds originating in establish- representative of the batch, that prove negative ments not certified as free of Avian Influenza and for Avian Influenza and whose parameters shall Newcastle Disease, shall only be permitted upon be defined by the DSA. The results of the serologi- submission of individual tests performed in an cal tests shall be valid for thirty (30) days; official laboratory, that prove negative for New- II – fowl and eggs originating in the estab- castle Disease and valid for thirty (30) days. lishments described in items V, VI, VII and VIII Art. 13. State Animal Sanitary Health and In- shall be accompanied with a GTA issued by an spection Agencies shall submit to the SFA by the official or accredited veterinarian, following the 10th day of the following month, the avian transit performance of serological tests representative report for information, evaluation, consolidation of the batch, that prove negative for Avian Influ- and further submission to the CSA/DSA. enza and whose parameters shall be defined by Art. 14. Twelve (12) months after the date of the DSA. The results of the serological tests shall publication of this Normative Instruction, the sale be valid for seven (7) days. of live domestic birds by commercial establish- III – clear eggs originating in the hatcheries ments shall only be permitted when the conditions described in item VIII shall be accompanied with set forth in the paragraphs below have been met. a CIS issued by an official or accredited veterinari- Paragraph 1. The commercial establish- an, following the performance of serological tests ments should be registered with the state animal sanitary health and inspection agency. the birds; Paragraph 2. The birds sold shall originate - initial and final number of birds lodged in establishments certified by the PNSA and be per house; accompanied with a GTA issued by the official or - diseases detected in the batch during accredited veterinarian technically responsible lodging; for the establishment of origin. - type of treatment to which the batch has Paragraph 3. With respect to control of the of- been submitted, with specification of the thera- ficial service, a record containing information on peutic agent used and length of treatment, includ- the origin and destination of the birds as well as ing the use of vaccine against Newcastle Disease; the sanitary measures carried out during lodging - date and time when food was suspend- and mortality shall be kept at the establishment ed; and and made available for inspection whenever so - signature of the veterinarian responsible requested. Furthermore, the establishment shall for the establishment. keep a descriptive memorial of the biosafety ac- Paragraph 1. When the analysis of the Sani- tions taken during lodging of the animals, includ- tary Report indicates a mortality rate equal to or ing disposal of remains and carcasses. higher than 10% during lodging of the birds in Art. 15. The Coordination Unit of Veterinary the establishment of origin, the SIF Federal Ag- Products of the Department of Surveillance of riculture and Livestock Inspector (a veterinarian) Livestock Inputs (CPV/DFIP) shall control and su- shall collect serum, cloacal and tracheal swab in pervise the distribution of vaccines against Avian up to 1% of the birds in the batch for further for- Influenza and Newcastle Disease, as regards the warding to the Official Laboratory, and notify the amount of vaccines produced and imported and SIPAG which, in turn, shall inform the SEDESA. the amount distributed by UF. Paragraph 2. When the analysis of the Sanitary Sole paragraph. The map showing the dis- Report indicates a mortality rate above 10% within tribution of registered vaccines shall be delivered a period of less than seventy two (72) hours from by producing and importing companies, on a lodging of the birds in the establishment of origin quarterly basis, to the CPV/DFIP, which will be re- to issuing of the sanitary report, or where such sponsible for forwarding it to the DSA. mortality rate is equal to or higher than 1% during Art. 16. The sanitary report referred to in transportation of the birds from the farm to the Administrative Ruling DAS No. 210 of April 10, slaughterhouse, or the report shows suggestive clin- 200 1998, Annex IV, shall be delivered to the Federal ical signs of Avian Influenza or Newcastle Disease in Inspection Service (SIF) 24 hours before the birds the bird batch, the Animal and Plant Health and are scheduled to be slaughtered, and contain the Inspection Service (SIPAG) and the Agriculture and following information: Livestock Health and Inspection Service (SEDESA) - data on the establishment of origin of shall be immediately notified.

NORMATIVE INSTRUCTION No.78 OF NOVEMBER 3, 2003

Published in the Official Gazette of April 10, 2006 Section 1, Page 06

Approves the Technical Rules for the Control and Certification of Poultry holdings and Nucleis, such as, free of Salmonella gallinarum and of Salmonella pullorum, and free or controlled for Salmonella enteritidis and Salmonella typhimurium

THE SECRETARY OF ANIMAL AND PLANT AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, by HEALTH AND INSPECTION, OF THE MINISTRY OF the powers invested in him in article 15, clause II, of Decree No.4.629, of March 21, 2003, in view and Nucleis, such as, free of Salmonella gallinar- of what is disposed by Ministerial Act No.193, um and of Salmonella pullorum, and free or con- of September 19, 1994, which creates the Na- trolled for Salmonella enteritidis and Salmonella tional Avian Health Program (PNSA), and what typhimurium, attached. is stated from Process No.21000.009818/2003- Art. 2. This Normative Instruction will be in 19, decides: effect on the date of its publication. Art. 1. To approve the Technical Rules for the Art. 3. Is hereby repealed Normative In- Control and Certification of Aviary Establishments struction No.03, of January 9, 2002.

MAÇAO TADANO

ANNEX

TECHNICAL RULES FOR THE CONTROL AND CERTIFICATION OF POULTRY HOLDINGS AND NUCLEIS, SUCH AS FREE OF SALMONELLA GALLINARUM AND OF SALMONELLA PULLORUM, AND FREE OR CONTROLLED FOR SALMONELLA ENTERITIDIS AND SALMONELLA TYPHIMURIUM.

CHAPTER I 5. The importing businesses or purchasers of genetic material of pure breeds, great INTRODUCTION grandparents and grandparents, must present the guarantee or certification as to free of the 1. These rules define the measures of constant salmonellas in these rules. monitoring salmonellosis in aviary businesses permanently and eventually controlled (except CHAPTER II commercial position, poultry for slaughter and ratites), that perform the commerce or trans- DEFINITIONS ference, domestic and international, of their products, intended for breeding and for the 1. For the purpose of these rules, it is un- production of poultry and hatching eggs, hav- derstood: 201 ing to perform monitoring of their flocks, obey- 1.1. Batch: group of poultry for the same ing the directions of the National Avian Health purpose, origin and age, lodged in one or many Program (PNSA). barns. 2. To proceed to the domestic and inter- 1.2. Boxes: are physical divisions inside a national market, and with transference, in the barn. national ambit, of derived products, the aviary 1.3. Barn: is the aviary production unit, center or business must be certified as free of characterized as the unit of a center, which Salmonella gallinarum and Salmonella pullo- lodges a group of breeders, poultry for slaugh- rum, and free or controlled for Salmonella enter or commercial laying hens, of the same age teritidis and Salmonella typhimurium. (with exeption of pure breeds, genetically se- 3. The establishments of pure breeding lected), and of the same breed. businesses, great grandparents and grandpar- 1.4. Commercial poultry: generation of ents, must be free of all four salmonellas. poultry meant for slaughter and/or egg produc- 4. The establishments of parent breeders tion for consumption. must be free of Salmonella gallinarum and 1.5. Center of breeding: is the unit with an Salmonella pullorum, and free, and/or con- area adequately isolated, of comun handling, trolled for Salmonella enteritidis and Salmo- constituted of one or more barns. nella typhimurium. 1.6. Poultry holding: is the location where poultry is kept for any purpose, which may be 1.16. MAPA: Ministry of Agriculture, Live- constituted of one or more centers. stock and Food Supply. 1.6.1. Poultry holding permanently con- 1.17. SDA: Animal and Plant Health and In- trolled: they are the farms, genetically selected, of spection Secretariat. primary breeders (pure breeds), great grandparent 1.18. DDA: Animal Health and Inspection farms, grandparent farms, parent breeder farms, Department. farms of breeding stock free of specific pathogens 1.19. CLA: Animal Laboratory Coordinat- (SPF), and the hatcheries of these premises. ing Unit. 1.6.2. Poultry holding controlled eventu- 1.20. PNSA: National Avian Health Pro- ally: they are the poultry holding producing gram, Program established at the SDA/DDA. commercial eggs, poultry for slaughter, explor- 1.21. DIPOA: Department of Inspection of ing other wild birds, or ornamental, and/or ex- Animal Origin Products. otic, and the hatcheries of these premises. 1.22. DFA: Federal Agricultural Delegacy. 1.7. Official service: is the Federal, State, 1.23. SSA: Animal Health Service. and Municipal Animal Health and Inspection 1.24. SIF: Federal Inspection Service. Service. 1.25. RST: Rapid serum agglutination test. 1.8. Official laboratories: are the laborato- 1.26. CPV: Veterinary Product Coordina- ries of the Ministry of Agriculture, Livestock and tion. Food Supply (MAPA). 1.27. CPS: Surveillance and Health Program 1.9. Accredited laboratories: are the labo- Coordination. ratories of other federal, state, municipal, or private institutions, that have been approved CHAPTER III and recognized by the MAPA, to perform laboratory diagnosis of disease agents referred by FROM THE REQUIREMENTS TO BE these rules. FULFILLED BY THE POULTRY HOLDING 1.10. Federal Inspector or Official Veteri- narian: is the veterinarian of the Federal Ani- 1. To attend to the PNSA, the poultry holding mal Health and Inspection Service. of permanent and eventual controls must: 1.11. Official Veterinarian: is the federal in- 1.1. Be properly registered and qualified at spector or the veterinarian of the official service. the DFA of the State where they are located; 202 1.12. Official Veterinarian for certification: 1.2. Be under surveillance and control of the is the federal inspector or official veterinarian Animal Health Service of the DFA, and/or of the of the Animal Health and Inspection Service. Department executioner of State Health and In- 1.13. Official Accredited Veterinarian: is spection where the poultry holding is located; the official, state, municipal, private, or an in- 1.3. Be watched by a technical responsible dependent professional veterinarian, whom re- veterinarian that is registered at the DFA of the ceived delegation of competence of the federal State in which the establishment is located. official service to issue the Animal Movement 2. The poultry holding of Permanent Control Permit (GTA). will not be able to use: 1.14. Responsible Technician: is the veteri- 2.1. Any vaccines for salmonellosis at estab- narian responsible for the hygienic-health con- lishment permanently controlled, except as fore- trol at the flocks of Poultry holdings. seen in Chapter IV; 1.15. Monitoring of flocks: is the labora- 2.2. Any vaccine prepared with oily adjuvant tory health and analysis follow up, by means during the four weeks prior to the tests; of serological tests and other by other means, 2.3. Any drug scientifically proven to inter- on other biological material or not, and epide- fere in the results of serological tests, and/or in- miological analysis of the health conditions of terfere with the isolation of the salmonella in a poultry lodged in an poultry holding. period of three weeks prior to the tests; 2.4. At the parent hatchery premises, in ex- 6. Every three months the DDA by means of ceptional cases evaluated by the DDA, undergo- the CPS and the CPV, will confront the informa- ing medicated treatment for S. enteritidis and tion gathered by the technicians responsible for S. typhimurium, under the surveillance of the the properties described in item 2 of this chapter, MAPA, the evaluation will be provided according with the report issued by the manufacturer/im- to Chapter VIII in these rules. porter, referred in item 3 of this chapter. 3. Only controlled antigen and serum vaccines, approved by the MAPA, can be used, ob- CHAPTER V serving the expiration date. 4. Laboratory test will only be able to be used THE CERTIFICATION OF AVIARY when properly approved by the PNSA. CENTERS AND PREMISES 5. The poultry holding must forward to the DFA of the State of its jurisdiction, a monthly cal- 1. Certification of aviary centers and endar contemplating the schedules of birth, im- premises: portation and dates of routine samples provided 1.1. Free of Salmonella gallinarum (Fowl by the technician in charge, to give the Official Typhoid), and Salmonella pullorum (Pullorum Service the opportunity to adjust the dates of of- disease); ficial collection of samples, as well as to inspect 1.2. Free or Controlled for Salmonella enter- and supervise the referred establishment. itidis and Salmonella typhimurium; 1.3. Free or Controlled for S. enteritidis and S. CHAPTER IV typhimurium, and have received the vaccine for S. enteritidis; THE USE OF THE VACCINE FOR Salmonella enteritidis CHAPTER VI

1. At parent hatchery premises, it will only LABORATORY TESTS be allowed to use inactive vaccines for S. enteritidis; 1. The tests used for monitoring and labora- 2. The technician in charge for the parent tory test in the different stages of the process are: hatchery establishment must communicate 1.1. Rapid serum agglutination test – Pullo- 203 the usage of the vaccine to the MAPA, speci- rum disease Test (with blood or serum total); fying the location of the property, number 1.2. Tube agglutination test (TAT) or Micro- of poultry that received vaccination, the vac- agglutination test; cine program and its data (commercial name, 1.3. Bacteriologic Diagnosis. batch, starting number); 2. The implementation and interpretation of 3. The manufacturer/importer of the vac- laboratory tests mentioned in the previous item cine, must every three months communicate to must follow the rules established in legal acts, rules the MAPA, the list of users, and the number of and specific technical regulations of the MAPA. doses of the vaccine, which item 1 of this chap- 3. The laboratory exams will only be accept- ter regards to; ed when performed at official laboratories, and/ 4. Autogenous vaccines are authorized as or accredited by the MAPA for this matter, iden- long as it is used in the terms of the relevant tifying the antigen, the starting number, and the legislation; amount used. 5. It is herby prohibited the usage of any 4. The Rapid serum agglutination test with vaccine for salmonellas at grandparent hatchery blood total is considered a field test that is per- premises, at great grandparent hatchery estab- formed or supervised by the federal inspector, or lishment and at farms genetically selected from by a veterinarian technician, responsible for the the primary breeding stock (pure breeds). poultry holding by the MAPA. 5. Other laboratory exams may be used as long oratory chosen by the federal inspector, or by the as they are previously approved by the DDA/SDA. official veterinarian in charge of samplings. 8. The cost for official sample collections to CHAPTER VII be tested at a MAPA accredited laboratory plus shipping, will be the company’s responsibility. SAMPLES COLLECTION AND FORWARDING 9. Random samplings performed by the of- TO THE LABORATORY FOR TESTS ficial service may or not meet companies’ schedules, of which a federal inspector, or an official 1. The samples are collected for official veterinarian are responsible for, and also respon- monitoring, which will only be accepted when sible for securing the material, being of respon- performed by a federal inspector, or by an official sibility of the company to provide the necessary veterinarian, or by a professional from the poul- means and materials for this operation. try holding under official supervision. 10. The same criterions used for parent 2. To receive certification, the samples - for breeders will be applied for ornamental and warded to the MAPA, by the veterinarian, respon- wild poultry. sible technician, and/or of the random sampling performed by the official service, will be analyzed CHAPTER VIII by the SSA/DFA of the State. 3. All material forwarded for laboratory ex- PERFORMING LABORATORY TESTS amining must be officially sealed along with the standard DDA/SDA sampling form, filled out cor- 1. The system of laboratory exams for S. gal- rectly and signed by the responsible technician at linarum, S. pullorum, S.enteritidis and S. typhimu- the MAPA, and/or by the federal inspector, or by rium will include: the official veterinarian. 1.1. On breeding stock or hatching eggs, and 4. The official sampling must be performed commercial production for restocking imported randomly among the barns in the same center for, aviary flocks: serological tests, biological tests on SPF poultry, or 1.1.1. The sample collection will be per- on embryonated eggs, or bacteriological tests. formed on arrival, and the laboratory tests per- 5. With intensions of monitoring the health formed according to the specific rules for poultry condition and also certification management, and hatching egg importation and exportation, 204 besides regular sampling at pure breed premises, intended for breeding and commercial produc- great grandparent and granparent hatchers, the tion, and for restocking aviary flocks. monitoring must be performed directly by the 1.1.2. The poultry produced from pure federal inspector, or official veterinarian, pro- breeds, and great grandparent hatcheries born in viding random double sampling, at least once a Brazil, will follow the same procedure mentioned year, and forwarded to a accredited or an official in item 1.1.1 of this chapter, having its first sam- laboratory for analysis. pling performed in the Hatchery at the moment 6. DFA’s criteria as to the Animal Health Ser- of birth, and sent to the official laboratory by vice, and/or of the State Secretariat of Agricul- the Animal Health Service of the DFA in the State ture, of the sate in which the poultry holding is where it is located. located, at any time and in the presence of the 1.2. Health monitoring of aviary flocks. federal inspector, or of an official veterinarian, 1.2.1. 01 (one) to 05 (five) day old poultry: random double samplings may be collected to 1.2.1.1. Bacteriological diagnosis of the dead be submitted for laboratory exams, respecting poultry, identifying its genetic properties, maximum the criterions and rules of biosafety, at official or of 50 birds, and tray swabs (1 “pool” from each barn), MAPA accredited laboratories for this matter. and of paper (or shavings), from the crates. 7. The official monitored material for this 1.2.2. 12 week old breeding stocks: matter could be sent to any MAPA accredited lab- 1.2.2.1. Bacteriologic Diagnosis. Must be performed in at least one of the following sam- exams, which must be done on the 27 week of ples provided below, depending on the feasibility age, as per samples described in item 1.2.2.1. Or- and possibility of collecting the material: gans should also be collected (liver, spleen, ovary a “pool” of fifty cloacal swabs, using one and cecal tonsil) of at least 60 birds distributed ac- for every two birds, with a total of one hundred cordingly within the center’s aviaries. It ill be col- birds per center; lected in “pool”, separating bowels from cecal ton- or a “pool” of one hundred samples of sils, and gathering samples 10 birds per “pool”. fresh feces per center; 1.2.3.4. The samples mentioned in items or a “pool” of two drag swabs per barn in 1.2.3.2., and 1.2.3.3., must be taken by the Vet- the center. erinarian, technician in charge for the establish- 1.2.2.2. Rapid Serum Agglutination Test ment, and sent to the Accredited Laboratory along (RST) with the Official Sample Collection Term of the in one hundred samples per centers. When PNSA, the sample collection of the material, and as a reagent, it must be supplemented with the fulfillment of the test in item 1.2.3.1., must be Tube Agglutination Test, or Micro-agglutination accompanied by the Veterinarian, technician in test. charge for the establishment that must register all 1.2.3. Breeding stock poultry in the begin- the results of the test on the batch’s history file. ning of production: 1.2.4. Periodic control every three months. 1.2.3.1. Pure breeds, great grandparent 1.2.4.1. Poultry holding permanently con- and grandparent hatchers. trolled: 1.2.3.1.1. SAR on 100% of the poultry. 1.2.4.1.1. Bacteriologic Diagnosis. use the When as reagents, they must be supplemented same criterion described in item 1.2.2.1. of this with Slow Seroagglutination in Tubes, or Mi- chapter. croagglutination. 1.2.4.1.2. Bacteriologic Diagnosis in 1 “pool” 1.2.3.1.2. Bacteriologic Diagnosis. use the of twenty beaked eggs, and in fifty milliliters of same criterion described in item 1.2.2.1. of this meconium, (collected in the Hatchery) in refer- chapter. ence to the center being shown. 1.2.3.2. Parent hatcheries that were not 1.2.4.1.3. RST in one hundred samples per vaccinated. center. hen reagent, it must be supplemented with 1.2.3.2.1. RST of five hundred samples per Slow Agglutination in Tubes, or Microagglutination, 205 center. When as a reagent, it must be supple- except on poultry vaccinated for S. enteritidis. mented with Tube Agglutination Test, or Micro- Note: agglutination test. a) the repetitions are provided every three 1.2.3.2.2. Bacteriologic Diagnosis. use the months, until the batch is clean, allowing a varia- same criterion described in item 1.2.2.1. of this tion of up to two weeks, in a way to adapt the chapter. blood collection to other handling practices. Parent breeders that were vaccinated. 1.2.4.2. Establishment with eventual con- 1.2.3.3.1. In the first batch of chicks born trols for wild and/or ornamental birds (periodic from the center vaccinated, 200 samples of meco- control every 03 (three) months): nium will be taken from four “pools” of 50 birds. 1.2.4.2.1. Bacteriologic Diagnosis. use the Besides that, 150 non-born-beaked eggs, in ten same criterion described in item 1.2.2.1. of this “pools” of 15 eggs, for the accomplishment of the chapter. bacteriological exams, in “pool” of yolk, “pool” of 1.2.4.2.2. Bacteriologic Diagnosis in 1 “pool” liver, spleen and pouch (bursa of Fabricius), and of up to twenty beaked eggs, and in up to fifty mil- “pool” of caecum. liliters of meconium (collected in the Hatchery). 1.2.3.3.2. For centers exclusively intended to 1.2.4.2.3. RST of up to one hundred samples, the commercialization of hatching eggs, the con- or 100% on smaller populations, except for small trol must be provided by means of bacteriological poultry. When as a reagent, it must be supplemented with Tube Agglutination Test, or Micro- monella enteritidis and Salmonella typhimurium, agglutination test. Sampling will be calculated the virus-free certification will be cancelled, and with statistical basis, case by case. the aviary center or establishment will be con- 2. If detected the presence of serologically sidered controlled, as long as it meets the fol- reagent poultry in non vaccinated batches, in lowing criterions: the Tube Agglutination Test, or Micro-aggluti- 2.2.1. Suspension of egg incubation until re- nation test, the following procedures should be sults test negative, and adoption of the following followed: rules for the poultry of the outbreak: 2.1. At establishment of permanent control: 2.2.1.1. Medicate the center with specific an- 2.1.1. Isolation and Identification of the re- tibiotic therapy for enterobacterium; agent poultry, sanitary slaughter, and later send- 2.2.1.2. Laboratory Diagnostic procedures, ing the poultry collected and stored under refrig- according to Chapters VI and VIII, being that the eration, for bacteriological diagnosis, obeying the first test must be performed five days after end- following criterions: ing the antibiotic therapy. In case of testing posi- 2.1.1.1. If less than four birds, forward indi- tive, the antibiotic therapy is repeated along with vidual samples; the initial test plan, until results test negative. Af- 2.1.1.2. If more than four birds, forward ter receiving the first negative result, it is allowed “pools” of five samples of up to twenty birds. to resume incubation. Diagnostic procedures 2.2. At establishment of eventual control of performed every three months until sending the wild and/or ornamental poultry: poultry to be slaughtered; 2.2.1. Small and medium poultry: collect 2.2.1.3. Since they are pathogenic to man, its cloacal swab and feces of all reagent poultry, in products cannot be commercialized for human individual samples. consumption, must be saved if authorized by the DDA and DIPOA, and if industrialized at estab- CHAPTER IX lishment with the SIF. 2.2.1.4. The negative result on two consecu- INTERPRETATION OF RESULTS AND tive tests, will allow the center’s certification or APPLICATION OF SECURITY AND of the Poultry holdings, as being controlled for HEALTH CONTROL MEASURES Salmonella enteritidis and Salmonella typhimurium, free to commercialize one day-old birds, or 206 1. On poultry or hatching eggs of import- hatching eggs exclusively in nation territory. ed breeders, and pure breed poultry, great 2.2.1.5. The establishment considered as grandparent and grandparent hatchers born controlled must reinforce biosafety measures. in Brazil: 3. Wild and ornamental poultry for commer- 1.1. If the official samples test positive for cial production: will adopt the same criterions Salmonella gallinarum, Salmonella pullorum, used for parent breeders. Salmonella enteritidis and Salmonella typh- 4. If there are many death occurrences imurium – sacrifice and destruction/sanitary even after all demands were obeyed, the poul- slaughter of the center, and elimination of all try holding must inform the official service, the eggs, incubating or not, from the infected that will determine the sending of the mate- centers. rial of about thirty dead, or agonizing poultry, 2. Parent Breeders: to an official or MAPA accredited laboratory 2.1. If official sample tests positive forSalmo - with the objective of isolating S. pullorum, S. nella gallinarum, Salmonella pullorum, there will gallinarum, S. enteritidis, S. typhimurium. Af- be sacrifice and destruction/sanitary slaughter ter diagnosis is confirmed, the poultry from at the center, and elimination of all eggs, incu- the center will be sanitary slaughtered, and bating or not, originated from there. an epidemiological investigation will be per- 2.2. If official samples test positive for Sal- formed in search of the source. CHAPTER X of the SSA/DFA, and/or of the State Secretariat of Agriculture of the state in which the poultry hold- FORWARDING THE RESULTS ing is located.

1. The laboratory test results must be issued CHAPTER XII on a standard MAPA form, and communications according to the flowchart established: GENERAL DISPOSITIONS 1.1. Negative result: send FAX or use other means for the immediate communication to the 1. The serological laboratory exams are al- Requesting Official Veterinarian, and to the Poul- ways selected, with the possibility of occuring try holdings. nonspecific crossed reactions. Therefore, only 1.2. Positive result: send FAX or other type of the identification of the agent is considered ex- immediate documentation to the DDA and to the clusive for the confirmation of the four salmo- Animal Health Service/SSA/DFA, where the estab- nella serotypes referred in this rule. lishment is located. 2. It is mandatory to send all isolated salmonellas to the official laboratory, and of reference CHAPTER XI to aviary salmonella, to be investigated under the epidemiological/microbiological aspects. CERTIFICATION OF THE PREMISES 3. The commercialization of hatching eggs from outbreaks with S. enteritidis and S. 1. When the results of these laboratory exams typhimurium, cannot be used for human con- referred in Chapters VIII and IX of these rules, test sumption, saved if authorized by the DDA and negative for the center or Poultry holdings, the the DIPOA, according to the specific rules of Official Service will proceed with the aviary cen- the SIF. ter or premises’ certification as free ofSalmonella 4. The incubation of eggs from parent breed- gallinarum and Salmonella pullorum and free or ers controlled for Salmonella enteritidis and S. ty- controlled for Salmonella enteritidis and Salmo- phimurium must be done on separate machines nella typhimurium. from the icubators used for the eggs of infection 2. The poultry holding being certified as a free centers. free or controlled center will only be authorized 5. When slaughtering occurs at centers that to commercialize poultry or hatching eggs. tested positive for the reagents mentioned in this 207 3. The poultry holding that receive the infec- rule, they should be performed at the slaughter- tion free or controlled certificate, will be be able houses with the SIF, according to the DIPOA rules, to proceed with the commercialization of poultry or under the orientation of the SIF/DIPOA. and/or hatching eggs of all the centers. 6. The Animal Health Service of the DFA of 4. The DFA will issue a Health Certificate ac- the State in which the poultry holding is locat- cording to MAPA’s standard model, for the cen- ed, and the State Departments of Agriculture, ters or establishment free or controlled for the are the responsible and competent offices for agents treated in this rule, after performing at defining appropriate measures for handling least three tests. issues of nature, health, observing as estab- 5. The certificate will be valid for one year lished in the Animal Health Regulation and and obligated to the health maintenance situa- in the PNSA, of the Department of Livestock tion of the aviary center or of the premises. Protection. 6. If the flock’s health situation is altered, 7. The omissive cases and the questions cre- the certificate will be revoked, with the option ated in the application of this rule, and in com- of reinstating the certificate after the evaluation plementary acts will be voided by the DDA. NORMATIVE INSTRUCTION No. 11 OF SEPTEMBER 1, 2003.

Published in the Official Gazette of September 5, 2003 Section 1, Page 03

Declares the industrial avian flocks of the states of Santa Catarina, Rio Grande do Sul, Paraná, São Paulo, Minas Gerais, Goiás, Mato Grosso do Sul, Mato Grosso, and the Federal District free from Newcastle disease

THE STATE MINISTER OF AGRICULTURE, LIVE- viral activity for Newcastle disease in industrial STOCK AND FOOD SUPPLY, using the powers in- avian flocks in susceptible animals, finished in vested in him under art. 87, sole paragraph, item July 2003, and what is reported in Process No. II of the Constitution, in consideration of what is 21000.008236/2003-15, resolves: provided for by the Regulation of Animal Sanitary Art. 1. To declare the industrial avian flocks Health and Inspection, approved by Decree No. of the states of Santa Catarina, Rio Grande do 24.548 of July 3, 1934, Sul, Paraná, São Paulo, Minas Gerais, Goiás, Mato Considering the sanitary status of the indus- Grosso do Sul, Mato Grosso, and the Federal Dis- trial avian flock of the states of Santa Catarina, Rio trict, free from Newcastle disease. Grande do Sul, Paraná, São Paulo, Minas Gerais, Art. 2. To delegate authority to the Director Goiás, Mato Grosso do Sul, Mato Grosso, and the of the Animal Health Department to issue com- Federal District, where there has been no occur- plementary norms needed for the execution of rence of Newcastle disease for over five (5) years; this Normative Instruction. Considering the results obtained in se- Art. 3. This Normative Instruction comes roepidemiological survey for assessment of the into force on the date of publication thereof.

ROBERTO RODRIGUES

208 JOINT NORMATIVE INSTRUCTION No. 2 OF FEBRUARY 21, 2003

Published in the Official Gazette of February 25, 2003

Provides for the approval of technical regulations for registration, inspection, and sanitary control of ratite incubation, breeding, and housing establishments.

THE SECRETARIES OF ANIMAL AND PLANT of September 19, 1994; and Ministerial Norma- HEALTH AND INSPECTION AND OF RURAL SUP- tive Instruction no 4 of December 30, 1998, as PORT AND COOPERATIVISM OF THE MINISTRY OF well as Proceeding no. 21000.002092/2002-11, AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, by RESOLVES: virtue of the powers vested in them under Art. Art. 1. To approve the technical regulations 83, IV of SDA’s Internal Regulations approved un- for registration, inspection, and sanitary control der Ministerial Administrative Ruling No.574 of of ratite incubation, breeding, and housing es- December 8, 1998 and Art. 11, III, d; Art. 17, II, tablishments, complementary to Ministerial Nor- a of Decree No. 3527 of June 28, 2000; having mative Instruction No. 4 of December 30, 1998. in view the provisions of Decree 24548 of July 3, Art. 2. This Joint Normative Instruction shall 1934; Ministerial Administrative Ruling No. 193 be implemented by the Animal and Plant Health and Inspection and the Rural Support and Coop- Art. 3. This Joint Normative Instruction shall erativism Secretaries. enter into force on the day of its publication.

MAÇAO TADANO Animal and Plant Health and Inspection Secretary

MANOEL VALDEMIRO FRANCALINO DA ROCHA Rural Support and Cooperativism Secretary

ANNEX

TECHNICAL REGULATIONS FOR REGISTRATION, INSPECTION, AND SANITARY CONTROL OF RATITE INCUBATION, BREEDING, AND HOUSING

CHAPTER 1 1.1. Official Service: Animal Health Service at the federal, sate, and municipal level, and the RANGE OF APPLICATION service for inspection and development of animal production nationwide; These Technical Regulations apply, as appro- 1.2. Official Laboratories: Laboratories on priate, to the registration, inspection, and sani- MAPA’s chain of laboratories; tary control of establishments dedicated to ratite 1.3. Accredited Laboratories: Laboratories breeding, raising, rearing, fattening, housing, from other federal, state, municipal, o private and incubation, destined for breeding and com- institutions that have been qualified and recog- mercial production of products and subproducts nized by MAPA for the performance or labora- of ratites (ostriches and rheas), classified accord- tory diagnostic of the agents of diseases referred ing to their purpose. to hereunder; 1.4. Federal Agricultural and Livestock In- CHAPTER II spectors: Ministry of Agriculture, Livestock, and Food Supply inspectors trained in veterinary 209 CLASSIFICATION OF ESTABLISHMENTS medicine, entrusted with inspection and supervision related to Animal Health and Inspection. 1. For the purposes hereof, commercial They have the same attributions as veterinarians establishments dealing with ratites shall be clas- and zootechnicians charged with the inspection sified as follows: and supervision of animal production. 1.1 Hatchery 1.5. Official veterinarian for sanitary certifica- 1.2 Breeding tion: Federal Agricultural and Livestock Inspector 1.3 Raising and Rearing trained in veterinary medicine or veterinarian of 1.4 Fattening the Official Animal Health and Inspection Service; 1.5 Full cycle 1.6. Official Veterinary Control: Official ser- 1.6 Partial cycle vice familiar with the establishments where animals are kept, and with the owner’s or the person CHAPTER II in charge’s identity, which can enforce appropriate zoosanitary control measures as needed; DEFINITIONS 1.7. Accredited veterinarian: Official state and municipal veterinarian, either private or a 1. For the purposes hereof, the following liberal professional, that has been delegated by definitions apply: the Official Federal Service’s competence for issuing Animal Movement Permit (GTA); 1.18. Hatchery establishments: establish- 1.8. Technician in charge: veterinarian in ments destined for the incubation of hatching charge of the hygiene and sanitary control of eggss for the production of ratites; ratite flocks at rearing establishments, registered 1.19. Rearing establishments: establish- with the Federal Agriculture Enforcement Unit- ments destined for the production of reproduc- DFA in whose jurisdiction the establishments are ing parent breeders and ratites for slaughter; located; 1.20. Fattening establishments: establish- 1.9. Sanitary Certificate: sanitary inspection ments destined for commercial production of certificate describing the animal health and/or mature ratites for slaughter; public health requirements, pursuant to current 1.21. Full-cycle establishments: establish- legislation; ments engaged in all the aforementioned stages. 1.10. Animal Movement Permit-GTA: manda- 1.22. Partial-cycle establishments: establish- tory document required by MAPA for the transpor- ments engaged in one or more than one stage of tation of animals, including ratites and fertile ratite the production cycle; eggs for any movement and purpose thereof; 1.23. Commercial rhea raising establishments: 1.11. Transportation License: document is- establishments registered with IBAMA to foster the sued by IBAMA authorizing the transportation of management of wild ratites (rheas) under captivity wild animals between raising, breeding, and fat- for their economic exploitation or for trial; tening establishments, and flock movement; 1.24. Commercial ostrich raising establish- 1.12. Wild animals: all animals belonging to ments: establishments registered with MAPA for native, migratory, and any other water or land commercial exploitation or trial; species, whose life cycle has fully or partially oc- 1.25. Conservationist raising establishments: curred within the Brazilian territory or in waters establishments registered with IBAMA to foster under Brazilian jurisdiction; the management of wild ratites (rheas) under 1.13. Exotic animals: all animals whose geo- captivity to help environmental agencies in their graphic distribution does not include the Bra- projects or programs aimed at restoring the spe- zilian territory, and species introduced by man, cies to nature; including domestic animals gone wild. Some spe- 1.26. Scientific raising establishments: es- cies introduced out of the Brazilian territory or tablishments registered with IBAMA to foster the of waters under Brazilian jurisdiction which may management of wild ratites (rheas) under captiv- 210 have entered the Brazilian territory are also con- ity for supporting basic or applied scientific re- sidered to be exotic; search geared to the species studied or to public 1.14. Domestic animals: all animals that, or animal health; through traditional, systematized management 1.27. Zoological Garden: any collection of and/or zootechnical processes, have become do- living wild animals kept under captivity or in par- mestic and now display biologic and behavioral tial freedom and exposed to public visitation; characteristics in close dependence from man, 1.28. Discardable ratites: ratites with inad- and which may have a variable phenotype differ- equate zootechnical or sanitary characteristics ent from their wild species; for breeding; 1.15. Production animals: all wild, exotic, 1.29. Day-old ratites: birds up to seven days and domestic animals destined for breeding and after hatching, that have not taken any food or for the production of products and subproducts; drunk any water; 1.16. Ratites: Flightless running birds with- 1.30. Flock monitoring: sanitary follow-up out a keeled sternum (ostrich –Struthius camellus and laboratorial analysis performed at an official and emu, Rhea americana); or MAPA-accredited laboratory through serologic 1.17. Raising establishments: establishments tests and other tests in other materials, biologic destined for genetic selection and breeding, or not; and epidemiologic analysis of the health which produce hatching eggss and/or chicks; conditions of ratites housed in establishments; and proper interpretation of results; gram, under the SDA/DDA; 1.31. Registration: registration by MAPA 1.47. DIPOA: Department of Inspection of through the DFAs and by IBAMA through its Animal Origin Products; executive offices at the ratite raising, rearing, 1.48. DFA: Federal Agricultural Enforce- fattening, and hatchery, for which specific doc- ment Unit; uments and prior inspection by the official ser- 1.49. SSA: Animal Health Service vice are required; 1.50. SFFA: Animal Production Develop- 1.32. Register: an identification record kept by ment and Oversight Service; the official service; it is required for the registration 1.51. SIF: Federal Inspection Service of an establishment or rural property that houses 1.52. SARC: Rural Support and Cooperativ- ratites; a copy should be kept at the DFA and/or Ag- ism Office; ricultural Office’s local veterinary unit or executing 1.53. DFPA: Animal Production Develop- agency, for the purposes of sanitary monitoring; ment and Oversight Department; 1.33. Biosecurity: encompasses sanitary 1.54. IBAMA: Brazilian Institute for the En- measures, including measures pertaining to vironment and Renewable Natural Resources; cleaning and disinfection; control of the move- 1.55. INCRA: National Settlement and ment of people, animals, and vehicles; dis- Agrarian Reform Institute; carding; and security control of the facilities 1.56. CFMV: National Veterinary Medicine of establishments destined for incubation and Council; raising of ratites. These measures aim at ensur- 1.57. CRMV: Regional Veterinary Medicine ing the housed ratites’ sanitary status and their Council; health, thereby reducing the risk of introduc- 1.58. Breeders Association: association of tion and dissemination of diseases; ratite breeders of national prominence; 1.34. Hatching eggs: fertilized eggs, appro- 1.59. CC/PNSA: National Avian Health Pro- priate for incubation; gram’s Consultative Committee; 1.35. Infertile eggs: eggs that have not been 1.60. COESA: State Avian Health Commit- fertilized; tee; and 1.36. Commerce: the system of purchase, 1.61. CITES: Convention on International Trade sale, barter, exchange, transfer, loan, or dona- in Endangered Species of Wild Fauna and Flora. tion of ratites; 211 1.37. GPS: instrument that determines the geographical location of a property by satellite; CHAPTER IV 1.38. CNPJ: National Register of Legal Enti- ties; REGISTER AND REGISTRATION OF 1.39. CPF: National Identification of Natu- RATITE ESTABLISHMENTS (RAISING, ral Persons; REARING, FATTENING, FULL CYCLE, 1.40. MAPA: Ministry of Agriculture, Live- AND PARTIAL CYCLE) AND OF stock and Food Supply INCUBATION ESTABLISHMENTS 1.41. SDA: Animal and Plant Health and In- spection Secretariat; 1. Register: 1.42. DDA: Animal Health Department; 1.1. All ratite breeding and production es- 1.43. CPV: Veterinary Products Coordina- tablishments must be registered with the local tion Office; veterinary unit of the agency responsible for the 1.44. CPS: Sanitary Surveillance and Pro- state’s animal health policy. This will be required grams Coordination Office; for registration with the competent bodies. 1.45. CLA: Animal Laboratories Coordina- 2. Registration: tion Office: 2.1. Registration of commercial ratite 1.46. PNSA: National Avian Health Pro- breeding and production establishments shall be done by the following bodies: ment’s incorporation, including any modifica- 2.1.1. Ostrich – MAPA; tions, or of its registration with INCRA, or a lease 2.1.2. Rhea – IBAMA. contract duly entered into the records office of the 2.2. Registration of ostrich establishments municipality where the establishment is located. shall be done at MAPA, for which the initial regis- 1.2.2. A natural person must attach a copy of ter will be required from all establishments that his/her CPF identity document, accompanied by keep ostriches, irrespective of the number of a copy of his/her registration with the state trade birds; the process starts at the DFA of the state board or with INCRA, or of enrollment as a rural where the establishments are located, and will producer, or a lease contract duly entered into be concluded in conjunction with the animal the records office of his/her municipality. production inspection and development and the 1.3. A disclaimer by the veterinarian in animal health and inspection sectors, all consis- charge of the hygiene and sanitary control of es- tently with the sanitary norms and environmen- tablishments classified under Chapter II hereun- tal legislation in force. der, pursuant to MAPA’s standard form. 2.3. Registration with MAPA shall be done 1.4. Copy of the technician in charge’s reg- after evaluation by the state or municipal envi- istration with the Veterinary Medicine Council ronmental agency, and should include the evalu- (CFM or CRMV). ation report observations. 1.5. Duly filled-out MAPA standard registra- 2.4. Registration with IBAMA shall be done tion form. after that agency has issued the pertinent Operat- 1.5.1. In the case of rhea establishments, in ing License-LO. addition to registration with IBAMA, copies will 2.5. The registration document shall be is- be required of the registration document issued sued after technical inspections and submission on behalf of the veterinarian that has technical of the documents required by the respective responsibility for the establishment by the DFA in agencies. his/her jurisdiction, as well as a disclaimer of tech- 3. A report on the registrations done by MAPA nical responsibility on a MAPA standard form. (DDDA/SDA and DFPA/SARC) and IBAMA (Fauna 1.6. Proof of (microbiologic, physical, and and Fishery Recourses Office) shall be exchanged chemical ) potability of the water supply, issued and shared by these agencies on a half-yearly by a public, official, or MAPA accredited labora- basis, so that records may be kept current and tory, signed by the technician in charge, indicat- 212 consistent at the involved institutions. ing the source of supply. 1.7. Plan of the establishment, showing CHAPTER V all facilities, roads, water courses, and abutting properties on a scale compatible with the prop- DOCUMENTS AND REQUIREMENTS erty size, or aerophotogametric survey. FOR REGISTRATION OF RATITE 1.8. Plan on a scale technically appropriate ESTABLISHMENTS WITH MAPA for visualization of the property’s infrastructure and facilities. 1. Documents required for ostrich estab- 1.9. Description of facilities, equipment, and lishments: of the hygiene, sanitary, and biosecurity measures 1.1. Application to DFA in the state where to be adopted by the establishments, as well as of the establishment is located, pursuant to MAPA’s the technological incubation processes. standard form. 1.10. Protocol, register document, registra- 1.2. Legal data: tion, and prior license or importation license 1.2.1. A legal entity must attach a copy of its from IBAMA, as necessary. CNPJ identity document, accompanied by a copy 1.10.1. The IBAMA/Fauna and Fishery Resources of the establishment’s registration with the state Office importation license shall be required in case trade board or of the minutes of the establish- of ostriches and eggs originating in the wilderness. 1.10.2. For the importation of rheas, irrespective Ruling No. 70 of March 3, 1994. tively of their origin, in addition to a MAPA license or 1.1. The occurrence of other diseases subject authorization, a CITES license issued by IBAMA/Fau- to mandatory notification shall be notified to the na and Fishery Resources Office shall be required. Official Animal Health and Inspection Service on 1.11. Inspection report(s) in the state where a monthly basis. establishments are located shall be issued by the 1.2. Diseases subject to mandatory monitor- Federal Agricultural and Livestock Inspector or Of- ing shall be subject to the flow established by ficial Veterinarian from the Inspection and Devel- DDA/SDA/MAPA. opment sectors or services on the physical plant 1.3. Notification shall be done in person, and animal health, pertaining to hygiene and by telephone, radio, fax, e-mail or any other sanitary control; said reports shall be issued on a available means. MAPA standard form after on-site inspection; 1.4. Noncompliance with the provisions un- 1.11.1. Sanitary inspection may be done by a der the preceding articles shall be investigated state official veterinarian by MAPA delegation. by the official service, which will employ all the 1.12. Reports shall be issued by MAPA’s com- available means to establish liability. petent sector in one copy on a standard form. 1.4.1. In the case of veterinarians, in addition 1.13. A ratite establishment must inform the to abiding by the provisions under this article’s official service of the state where it is located, with- heading, the official service shall proceed in accor- in a maximum of 60 (sixty) days, of the change of dance with the specific professional legislation. technician in charge, and send his/her successor a disclaimer and pertinent documentation. CHAPTER VII 1.14. Any change of address or incorporation articles, as well as alienation or leasing must be SANITARY CONTROL brought current at MAPA, through the following: AND FLOCK MONITORING 1.14.1. Application to the Federal Agricul- tural Enforcement Unit in the state where the es- 1. As regards ratites or fertile ratite eggs for tablishment is located, requesting regularization commercial breeding and production: of its situation. 1.1. Importation: 1.14.2. Copy of the establishment’s new in- 1.1.1. Sample collection shall be done at the corporation articles or lease contract. entry points (ports, airports, and border posts) or 213 1.14.3. New inspection report(s) on the phys- on quarantine facilities as determined by DDA/ ical plant and hygiene and sanitary control. SDA/MAPA, for the performance of laboratorial 1.15. MAPA may enter a provisional registra- tests pursuant to specific legislation on importation at its discretion. tion and laboratories. 1.16. Registration with IBAMA/Fauna and Fish- 1.2. National flock: ery Resources Office shall be subject to the latter’s 1.2.1. Sanitary monitoring shall be perma- procedures and to the documentation it requires. nent at raising, housing, and hatchery establishments, pursuant to the norms established under CHAPTER VI the Animal Health and Inspection Regulations and under PNSA/DDA/SDA/MAPA. NOTIFICATION OF SUSPICION OR 1.2.2. Half-yearly Survey: OCCURRENCE OF AVIAN DISEASES 1.2.2.1. Isolation or Polymerase Chain Reac- tion (PCR) – (Salmonella gallinarum, S. pullorum, 1. Veterinarians, owners, or any other citizen S. enteritidis and S. typhimurium). aware or suspicion of the occurrence of Newcas- 1.2.2.2. Isolation or Polymerase Chain Reac- tle disease and Avian Influenza must promptly tion (PCR) – (Mycoplasma gallisepticum and M. notify the official service pursuant to Decree No. synoviae). 24548 of July 3, 1934 and Ministerial Administra- 1.2.2.3. Serology for Newcastle disease: 1.2.3. Other diagnostic methodologies may stances, and only if authorized by DDA-CPS/PNSA be accepted, once approved by DDA CPS/PNSA and CPV after risk evaluation and confirmation of and CLA. an epidemiologic situation. 1.2.4. Actions for the surveillance and eradi- 11. Only immunogenes, disinfectants, anti- cation of Newcastle disease and avian influenza gens, serum controls and kits registered with CPV/ shall be carried out in accordance with DDA-CPS/ DDA/SDA/MAPA may be used, and only before PNSA and CLA norms and specific legislation. their expiration date. 2. Sanitary monitoring shall be carried out 12. Only antigens an serum controls provid- through the collection of serum and trachea and ed or approved by MAPA may be used. cloaca or feces swabs from 10 percent of the flock 13. Laboratory tests shall be used, subject to per age group to be controlled, as follows: prior approval by DDA-CPS/PNSA and CLA. 2.1. Birds aged one day to six months; 14. Laboratory tests shall be accepted only if 2.2. Birds aged from six months up to the performed at an official or MAPA accredited labo- start of the breeding stage; ratory, and indicate the antigen used, the batch 2.3. Adult birds at the breeding stage or at rest. number, and the amount used. 3. Samples shall be collected from all birds 15. A ratite establishment that is a PNSA par- in flocks of up to twenty birds; or five to twenty ticipant may not use: samples may be collected per group; a pool of up 15.1. Any vaccine prepared with an oily sub- to five birds may be adopted, depending on the stance, in the four weeks prior to the tests; housed population. 1.5.2. Any drug for which there is scientific 4. The collection of samples from flocks evidence that it may interfere in the laboratory larger than twenty birds may be done by sample tests or hamper the isolation of agents to be re- pools per group, up to a maximum of fifteen searched, in the three weeks prior to the tests. birds per pool. 16. Other laboratory tests may be used, sub- 5. Monitoring analysis for the diseases men- ject to MAPA’s approval. tioned hereunder shall be performed at MAPA accredited or official laboratories. CHAPTER VIII 6. Systematic vaccination against Newcastle disease shall be optional in the states; its use in SAMPLE COLLECTION AND ratites is not recommended, unless indicated by FORWARDING FOR LABORATORY TESTS 214 the local epidemiologic situation. 7. Depending on each region’s epidemiolog- 1. Ratite establishments registered with local ic situation, after evaluation by the official ser- units shall submit to the local unit of the state in vice, vaccination of birds against the Newcastle which they are located, pursuant to the sanitary disease may be mandatory on properties under control requirements hereunder, a schedule of permanent control, and on avian establishments sample collection and a timetable for hatching with different ratite species and different produc- and importation, as well as the dates of routine tion categories it may be regularly done. collection of materials, to be performed by the 8. In emergency situations related to these technician in charge, for the purposes of moni- diseases, the Official Federal Service may estab- toring, inspection, and supervision by the official lishment vaccination plans for each area. service. 9. Vaccination against avian diseases must be 2. Collections for official monitoring and sur- performed with vaccines registered with and ap- veillance will be accepted only if performed by a proved by MAPA, according to current legislation, federal agricultural and livestock inspector or by as a prophylactic or disease control measure. an official veterinarian, or under his supervision 10. In the case of avian influenza, as it is an and oversight. exotic disease in the country, vaccination shall 3. For the purposes of sanitary monitoring not be permitted, save under exceptional circum- for the issuance of sanitary certificates and GTAs, the SSA/DFA of the state where the ratite estab- CHAPTER IX lishment is located will analyze the samples forwarded by the technician in charge, responsible ISSUING OF LABORATORY RESULTS for the enterprise before MAPA, as well as random samples collected by the official service. 1. Laboratory test results shall be issued by 4. Any material destined for laboratory tests the accredited or official laboratory on the appro- must be accompanied by a duly filled-out MAPA priate MAPA standard form, in addition to notifi- collection standard form, signed by the enter- cations, according to the following procedure: prise’s technician in charge accredited before 1.1. Negative results: should be sent by fax, MAPA or by the federal agricultural and livestock e-mail, or other fast means of communication inspector, or by the official veterinarian. to the federal agriculture and livestock inspec- 5. Material for biologic tests or for bacterio- tor or to the official veterinarian that requested logic, mycoplasmatic, and virologic tests should the test, as well as to the ratites establishment be collected randomly. in question. 6. At the discretion of the Animal Health 1.2. Positive results: should be sent by fax, Service and/or the State Agricultural Department e-mail or other fast means of communication to or the executor of these regulations in the state the DDA and to the SSA/DFA in the state where where an establishment is located, double sam- the establishment is located, which will notify the ples may be collected at any time in the presence establishment. of the federal agriculture and livestock inspector or of the official veterinarian, to be subjected to CHAPTER X confirmation or complementary tests. 7. Official monitoring material may be sent TREATMENT, CONTROL, to any of the laboratories accredited by MAPA for AND CERTIFICATION MEASURES this purpose, at the discretion of the federal agriculture and livestock inspector or of the official 1. In case of positive laboratory test results: veterinarian responsible for the collection. 1.1. Specific surveillance, control, and eradi- 8. Monitoring samples shall be distribut- cation of Newcastle disease and avian influenza ed by drawing lots among official laboratories legislation should be applied. and MAPA accredited laboratories for this pur- 1.2. In case of salmonellosis and myco- 215 pose. The drawing of lots shall be followed by plasmosis: the federal agriculture and livestock inspector 1.2.1. Breeding ratites should be monitored or the official veterinarian responsible for the for salmonellosis (S. gallinarum, S. pullorum, S. collection. enteritidis and S. tiphimurium) and for myco- 9. Costs pertaining to the laboratory tests and plasmosis (Mycoplasma gallisepticum and M. shipment of samples to the laboratory accredited sinoviae). by MAPA for this purpose shall be incumbent on 1.2.1.1. Complementarily, all isolated Salmo- the establishment or enterprise. nella serovars must be typified and subjected to 10. Any officially collected material should epidemiologic investigation in relation to the risk be sealed and accompanied by the DDA/SDA/ to the ratite flock and to public health. MAPA standard form. 1.2.1.2. Salmonella pullorum and Salmonella 11. Random collections done by the official gallinarum are considered as posing a risk to the service may or may not abide by the enterprises’ avian flock, whileSalmonella enteritidis and Salmo- tests timetable; the federal agriculture and live- nella tiphimurium pose a risk to public health. stock inspector or the official veterinarian re- 1.2.1.3. Positive cases of salmonellosis in ra- sponsible for collections or for overseeing them tites destined for slaughter should be notified by shall be responsible for sealing the material and the Official Animal Health Service to the Official sending it to the laboratory. Animal Products Inspection Service (SIF/DIPOA/ MAPA), which will determine slaughter criteria 1.5.4. From other avian raising establish- pursuant to the specific norms and legislation. ments of different exotic or wild species to be 1.2.1.4. In view of the risk to public health sold on the pet market or for the production of and to animal health, pertinent hygiene and parent breeders: 4 km. sanitary measures defined by DDA should be ap- 1.5.5. Between ratite establishments and es- plied in breeding pens where proven salmonella tablishments geared to industrial poultry farm- positive birds have been kept. ing, breeding (pure breeds, grandparents, great- 1.2.2. Proven positive mycoplasma breeding grandparents, and parent breeders), SPF poultry, ratites may be treated with specific antibiotic, and breeding hatchery: 11 km. and the flock must remain under control and 1.6. From raising facilities to the property’s monitoring. boundaries: 25 m, including hedges or wall. 1.3. After at least three consecutive tests with 1.7. From full-cycle or partial cycle rais- negative results for salmonellosis and mycoplas- ing, rearing or fattening establishments to the mosis, a certificate for the property or breeding main paved road giving access to the estab- sector thereof shall be issued by the official ser- lishment: 50 m. vice, testifying that they are free of or under con- 1.8. Between ostrich groups of different trol for the diseases investigated. ages: 100 m. 1.9. Between hatcheries of ratites of the CHAPTER XI same species and raising pens within the property: 50 m (with the adoption of biosecurity mea- BIOSECURITY OF THE SYSTEM sures and separate facilities). FOR RATITE RAISING ESTABLISHMENTS 1.10. Between commercial rhea and ostrich production establishments and free-ranging, 1. Establishments must be on an appropriate wild rheas: 25 m (with the adoption of biosecu- geographic location and maintain the following rity measures and separate facilities). distances to other ratite or avian establishments 2. Any procedures for releasing or introduc- with different production purposes: ing birds into the wilderness is hereby strictly for- 1.1. From a ratite establishment to an avian bidden, as this leads to environmental degrada- slaughterhouse: 5 km. tion, entailing consequences that adversely affect 1.2. From a ratite establishment to a feed the biota, and is subject to the penalties under 216 plant: 3 km. Law 6938/81 and Law 9605/98. 1.3. From other avian raising establishments 3. At the discretion of the federal agriculture to quarantine facilities for imported ratites: 11 km. and livestock inspector or, by delegation, of the 1.4. From a paved road to the entrance of federal or state official veterinarian responsible quarantine facilities for imported ratites: 4 km. for inspection and for issuing the operation per- 1.5. From a ratite establishment to another mit, modification of the aforementioned mini- avian breeding or housing establishment: mum distances may, after sanitary risk evalua- 1.5.1. Between establishments holding ratite tion, be allowed on pre-existing establishments, species that are similar or different from each in view of the existence of barriers (reforestation, other: 500 m. natural woods, topography, masonry walls, access 1.5.2. Between establishments holding dif- control, etc.) of the employment of differentiated ferent ratite species on the same property: 100 m management and biosecurity measures that pre- (subject to the adoption of biosecurity measures vent the introduction and spread of pathogens. and separate facilities). 4. In the case of hatchery, inspection by the 1.5.3. Between ratite raising establish- official service is mandatory, to ensure the bios- ments and other industrial poultry estab- ecurity and the health of new-born ratites, in this lishments for broilers, layers, or for turkeys, evaluation, shall be considered the existence of quails, partridges, etc: 4 km. masonry walls, hedges, or wire mesh fences separating production and incubation areas, with a separated by fences and/or a palisade of trees single entrance, provided with a footbath and other than fruit trees; the area must have restrict- shower to be used before entering the clean area. ed, controlled access of vehicles, people, and ma- 5. Control of vectors and rodents and of the terials, and biosecurity measures pertaining to access of other birds and of people. the internal area must be in place. 6. Adoption of monthly microbiological san- 18. Admission of people, vehicles, equip- itary control for plating of facilities and equipment, and materials into the establishments’ in- ment, and testing at an accredited or official ternal areas should be permitted only after strict laboratory; and observation of local situations. compliance with biosecurity measures. 7. Properties must be located at a minimum 19. Control measures pertaining to liquid of 25 m from secondary roads, from which they effluents must be adopted, consisting of septic should be separated by a perennial security hedge. tanks, taking into account water courses and un- 8. Only one entrance should give access to derground waters to prevent contamination, pur- the property, be protected by security fences, suant to environmental and health norms. and be equipped with a system for the disin- 20. Physical and chemical control of water fection of vehicles and materials as they enter on a yearly basis; and half-yearly microbiologic or leave the property. control done at a public, official, or MAPA accred- 9. The property must maintain strict control ited laboratory, with indication of the source of of the transit and access of people (gates, doors, the establishment’s water supply. reception desk, masonry walls, footbath, and 21. At the discretion of the Official Animal other items). Health Service, after evaluation by DDA/SDA/ 10. Facilities’ interior wall surfaces must MAPA, and according to each region’s epidemio- be such as to permit proper cleaning and dis- logic and sanitary situation, measures may be infection. adopted to restrict the transit of vehicles, people, 11. The inner fence of adult ostrich pens may and/or animals in regard to circumscribed regions be of plain wire or wire mesh, 1.70-m high; and and establishments referred to hereunder, for the there must be a 2-m wide corridor between pens. purpose of disease control and mandatory vac- 12. Pens must give out on a corridor leading cination against Newcastle disease or other dis- to isolation pens measuring a maximum of 4 m2 x eases likely to place breeding flocks, wild birds, 5 m2 for sanitary inspection, collection of materi- and ratites or public health at risk. 217 als, medication, and other purposes, as needed. 22. Ratites and eggs produced should be in- 13. In raising and rearing pens (for birds aged dividually identified. 4 to 14 months), fences must be of plain wire of 22.1. Live ratites: an open or closed ring; a at least five wires and be 1.70 m high, or of wire clamp (eartag adapted to the wing), or electronic mesh, measuring 50 cm in height from the ground marking or tattoo with antitoxic ink. and with plain wire in the upper part; an area of 22.2. Eggs: stamp or pen with antitoxic ink 100 m2 per bird (ostrich) is recommended. insoluble in water, or pencil, with the registration 14. Space for adult ostriches may vary from number, laying date, or any other kind of mark- 165 m2 to 500 m2 per bird, i.e., 20 to 60 birds ing that ensures identification. per hectare. 22.2.1. Whenever possible, besides informa- 15. Inside pens there must be feed and wa- tion referred to in the preceding item 22.2, it ter troughs. should include paternity information. 16. Establishments must have means, duly 23. At the property’s entrance, biosecurity mea- approved by MAPA and by the competent ensures and procedures for the disinfection of vehicles, vironmental control bodies, for the disposition equipment, and materials must be adopted. of production residues (dead birds, excreta, egg 24. Eggs destined for human consumption remnants, and packaging, among others). shall be subject to sanitary procedures pursuant 17. Birds of different age groups must be to SIF/DIPO/SDA/MAPA norms. tion of the aforementioned minimum distances 25. Egg collection in the open should be may, after sanitary risk evaluation, be allowed on done at least once a day. pre-existing establishments, in view of the existence of barriers (reforestation, natural woods, CHAPTER XII topography, masonry walls, access control, etc.) or of the employment of differentiated manage- BIOSECURITY OF THE SYSTEM ment and biosecurity measures that prevent the FOR RATITE HATCHERY introduction and spread of pathogens. 5. A permanent sanitary monitoring pro- 1. Facilities must have only one entrance gram must be established pursuant the Animal and permit one-way flow, and access to them is Health and Inspection Regulations and to PNSA/ subject to the requirements referred to in Chap- DDA/SDA/MAPA norms. ter XI, 1 hereunder. 6. Monthly microbiologic monitoring dur- 1.1. Incubation establishment facilities ing the incubation period through the plating of should be divided into separate work areas (offic- each incubation area and equipment (incubators es and technical facilities), physically separated, and hatching area), done at accredited or official with individual ventilation, and should include laboratories. the following: 7. Control measures pertaining to liquid ef- 1.1.1. Room for receiving and cleaning fluents must be adopted, consisting of septic hatching eggs. tanks, taking into account water courses and un- 1.1.2. Fumigation chamber for hatching eggs derground waters to prevent contamination, pur- (optional). suant to environmental and health norms. 1.1.3. Eggs storage room. 8. Biosecurity measures should be adopted, 1.1.4. Incubation room. such as a footbath at the entrance of the incuba- 1.1.5. Hatching room. tion facility, and efficient measures for the disin- 1.1.6. Maternity room. fection of vehicles at the property’s entrance. 1.1.7. Day-old birds shipping room (optional, 9. Exceptionally, in the case of rheas, natu- provided it is possible to maintain a downtime of ral incubation may be admitted, as well as the at least 72 hours). breeding of naturally or artificially incubated 1.1.8. Room for washing and disinfection chicks by foster parents. 218 equipment. 1.1.9. Locker room, washrooms, and toilets. CHAPTER XIII 1.1.10. Office. 1.1.11. Crate storage outside the incubator. BIOSECURITY MEASURES 1.1.12. Machine and generator room. FOR THE TRANSPORT OF EGGS 1.1.13. Adequate system for discarding incu- FOR INCUBATION bator residues and waste water. 2. All materials and equipment used in the 1. Eggs for incubation should be collected at hatchery must be kept clean and disinfected with regular intervals (at least once a day) in clean, dis- appropriate products duly registered with MAPA. infected recipients, and the personnel in charge 3. The area surrounding the incubation fa- of collection must wash their hands before. cility must be protected by a single entrance 2. Eggs and birds produced should be in- equipped with vehicle washing and disinfection dividually identified in respect of parents, pa- means for controlling any kind of transit. ternity and/or production pens or the property 4. At the discretion of the federal agriculture of origin. and livestock inspector or of the federal or state 3. Eggs that do not meet the hygiene, sani- official veterinarian, responsible for inspection tary, shell porosity and thickness standards, that and for issuing the operation permit, modifica- are broken, or have cracks should be collected in separate recipients and may not be destined for in the state where the establishment is located, incubation. according to administrative proceedings, while 4. After collection, eggs should be disin- respecting the right to defense. fected as soon as possible and be stored in an 2. An interested party may request cancella- appropriate place, under adequate temperature tion of its registration by applying to the federal and humidity. agriculture and livestock inspector in the state 5. Eggs should be transported from the in- where the ratite establishment is located. cubation establishment in appropriate vehicles, 3. Penalties imposed on the establishment in clean, previously disinfected trays or boxes/ shall be defined after technical evaluation by the carts, duly accompanied by a GTA whenever tran- federal agriculture and livestock inspector or, by sit from the breeding to the incubation facility is delegation, by the veterinarian of the state offi- necessary. cial service(s), in accordance with the following 5.1. In the specific case of rheas, a transpor- criteria: tation permit from IBAMA shall also be required. 3.1. Written warning notice: in case of noncompliance with one of more than one provision CHAPTER XIV of Chapters IV, V, VI, VII, VIII, X, XI, XII, XIII, XIV, and XVI hereunder. The notice shall set a dead- BIOSECURITY IN THE HANDLING line for resolution of the sanitary situation or for OF HATCHING EGGS AND DAY-OLD ensuring the requisite adequacy of the establish- RATITES ment facilities. 3.2. Establishment’s interdiction: in case of 1. Personnel engaged in the internal work noncompliance with technical determinations by of an incubation facility must follow the general the established deadline or with one or more than personal hygiene measures, and wear clean, dis- one provision under Chapters VI, VII, VIII, X, XI, XII, infected clothing and shoes provided by the incu- XIII, XIV, and XVI hereunder, which entails the risk bation enterprise. of spreading diseases through the ratite flock, the 2. Day-old ratites must be shipped directly wild fauna, and the national avian flock, or based from the incubation facility to the local destina- on suspicion or confirmation of an outbreak of tion, duly accompanied by a GTA on the way be- an exotic disease, as established under the Animal tween the two establishments. Health and Inspection Regulations. 219 2.1. In the specific case of rheas, a transpor- 3.3. Temporary suspension of registration: in tation permit from IBAMA shall be required. case of an infraction that entails a risk to pub- 3. Transport vehicles must be cleaned and lic health, biosecurity, the ratite flock, the wild disinfected prior to every shipment. fauna, and the national avian flock through the 4. Natural residues from day-old ratite in- spread of diseases, or to the safety of the estab- cubation and hatching should be incinerated, lishment’s physical structure. cremated, or subjected to another treatment ap- 4. The administrative proceeding shall be proved by MAPA and IBAMA or by state and mu- started by DFA in the state where the establishment nicipal environmental control agencies, so as to liable to punishment is located; recourse shall be prevent the spreading of any pathogens. allowed, within fifteen days from the date the interested party receives the notification, to the MAPA CHAPTER XV central organ, which depending on the reasons for interdiction will entrust the proceeding’s evalua- CANCELLATION OF REGISTRATION tion to SARC and SDA as the competent bodies. 5. In case of failure on the part of the in- 1. An establishment’s registration may be terested party to comply with the established re- cancelled at the request of the interested party quirements, registration with MAPA/DFA may be or by decision of the competent DFA authority definitively cancelled. 6. Communications regarding penalties 6. In an emergency, MAPA or the official imposed on raising establishments by MAPA or Animal Health and Inspection Service may inter- IBAMA must be promptly exchanged between lo- vene, safeguarding the provisions under the Ani- cal and national organs, within a maximum of mal Health and Inspection Regulations and the five business days. PNSA/DDA/SDA/MAPA. 7. At the discretion of the official service(s) 7. The sanitary control of commercial pro- in the state where the establishment is located, duction ratites shall be incumbent on MAPA and DFA may grant the interested party a new reg- the State Agriculture Departments or their execu- istration, subject to a new technical inspection tor agencies, by delegation. of the establishment and to the solution of the 8. All ratite production establishments must problems identified earlier, taking into consider- comply with PNSA norms and legal acts and com- ation the enterprise’s appropriate conduct, after ply with the following: new proceedings have been filed with the afore- 8.1. Meet biosecurity requirements, and mentioned DFA. grant federal agriculture and livestock inspector(s) and official service veterinarian(s) access to docu- CHAPTER XVI ments and facilities at any time. 8.2. Keep records of the annual physical GENERAL DISPOSITIONS and chemical control and of the half-yearly microbiologic potability control, as well as of water 1. Under agreements with MAPA, the SSA/DFA treatment at the establishment, the treatment of in the state where the establishment is located, liquid effluents, and the cleaning of equipment and the Animal Health Service of State Depart- and facilities. ments of Agriculture, in their area of operation 8.3. Keep records of the sanitary monitoring and competence, are responsible for defining the procedures pertaining to each batch of ratites proper measures for solving sanitary problems, and hatching eggs in relation to the diseases re- pursuant to the Animal Health and Inspection ferred to under PNSA/DDA/SDA/MAPA. Tests must Regulations and the PNSA/DDA/SDA/MAPA. be performed at a laboratory accredited by MAPA 2. All establishments that hold ratites or infor this purpose, or at an official laboratory; lab cubate ratite eggs shall be subject to sanitary in- results should be made available to the official spection by official services. services’ veterinarian authorities at request. 220 3. As they belong to the wild fauna, rheas 8.4. The technician in charge must send the should be managed according to the norms of flock’s epidemiologic bulletin to the local official IBAMA/Fauna and Fishery Resources Office; service on a monthly basis. those raised for commercial production shall be 8.5. Records must also be kept on the flock’s further subjected to specific sanitary monitoring management as regards each batch of birds and by PNSA/DDA/SDA/MAPA. At other rhea holdings, of hatching eggs, including information on mor- sanitary monitoring shall be occasional. In spo- tality, diseases diagnostic, sanitary monitoring, radic cases, monitoring shall be done through treatments, vaccination, etc. Said records should random sampling determined by PNSA/DDA/ be available to the official services’ veterinarian SDA/MAPA and IBAMA, so as not to interfere with authorities at request. free-range raising. 8.6. The establishment must submit a tri- 4. In view of the differentiated rhea produc- mestral report to DFA’s competent sector in the tion system, it is hereby established a deadline of state where it is located, pursuant to a standard 18 months of the publication date for the adapta- MAPA form, under penalty of its registration’s tion of physical facilities. cancellation. 5. The sanitary and health control of ratites 9. Depending on a situation identified by kept in zoos shall be incumbent on qualified pro- the official service(s), noncompliance with the re- fessionals at these institutions. quirements hereunder shall entail the adoption of the sanctions set forth under Chapter XV here- aspects, in consultation with ratite breeders as- under, cumulatively with the following: sociations with national representativeness. 9.1. Suspension of the authorization for ra- 13. Under the Animal Health and Inspection tite and hatching eggs importation, exportation, Regulations and PNSA, the regulation, regulariza- marketing, and the attendant issuing of GTA. tion, and control of animal health and biosecu- 9.2. Interdiction of the raising or hatchery. rity measures shall be incumbent on DDA/SDA/ 9.3. Application of the sanitary measures un- MAPA. der PNSA or of pertinent zootechnical measures 14. The cleaning and disinfection measures set by DFPA/SARD/MAPA. adopted must comply with the criteria estab- 10. Ratite establishments engaged in interna- lished by OIE and the specific national legisla- tional trade must also comply with the norms es- tion. tablished by MAPA and IBAMA/Fauna and Fishery 15. MAPA/SDA/DDA and DFA, each within its Resources Office-CITES for this purpose, as well as area of competence, may convene the Consulta- meeting the importing countries’ requirements. tive Committee of the National Avian Health Pro- 11. IBAMA, pursuant to its legal competence, gram (CC/PNSA) and the State Avian Health Com- shall proceed to the registration of all breeders mittees (COESAs) as needed to hear their views on and establishments that keep rheas, ostriches, specific issues hereunder. and other ratites in captivity for scientific and 16. Omissive cases and doubts that may rise conservation purposes and in zoos. in the application of these technical regulations 12. The DFPA/SARC/MAPA shall issue com- and of complementary legislation shall be de- plementary norms pertaining to zootechnical fined by MAPA, DDA/SDA or DFPA/SARC.

NORMATIVE INSTRUCTION SDA No. 32 OF MAY 13, 2002

Published in the Official Gazette of May 14, 2002, Section 1, Page 28

Approves the technical rules of surveillance for the Newcastle disease and avian influenza, and of control and eradication of the Newcastle disease 221 THE SECRETARY OF ANIMAL AND PLANT 21000.006729/2001-59, decide: HEALTH AND INSPECTION, OF THE MINISTRY OF AG- Art. 1. To approve the Technical Rules of RICULTURE, LIVESTOCK AND FOOD SUPPLY, by the surveillance for Newcastle disease and Avian In- powers invested in him in article 83, clause IV, of fluenza, and of control and eradication of New- the Internal Regulation of the Secretariat, approved castle disease. by Ministerial Administrative Ruling No.574, of De- Art. 2. This Normative Instruction will be in cember 8, 1998, in consideration and in light of the effect on the date of its publication. provisions of the Ministerial Administrative Ruling Art. 3. Is hereby repealed the Administrative No.193, of September 19, 1994, and in File MA Ruling SDA No.183, of November 8, 1994.

LUIZ CARLOS OLIVEIRA ANNEX

TECHNICAL RULES OF SURVEILLANCE FOR THE NEWCASTLE DISEASE AND AVIAN INFLUENZA, AND OF CONTROL AND ERADICATION OF THE NEWCASTLE DISEASE.

113-116, correspondents to residues 4 to 1, from CHAPTER I the cleavage area. In case the typical aminoacid residues can- INTRODUCTION not be distinguished, such as the description above, it is suitable to distinguish the isolated 1. The current rule defines surveillance mea- virus determining the pathogenicity index in the sures for the Newcastle disease and avian influ- brain (RESOLUTION No.XIII, of May 1999, issued enza, and of control and eradication being ap- by the international OIE committee; OIE Zoosan- plied to the Newcastle disease: itary Code, 2001). 1.1. In the surveillance at the port of entry, 2. AVIAN INFLUENZA: is a poultry infectious focusing on the health control of poultry and ge- disease that is caused by a virus of the Orthomixo- neric material from imported poultry. viridae family, of Influenzavirus A, B that present 1.2. At poultry holdings permanently con- an Intravenous Pathogenicity Index (IPIV) > 1.2 on trolled, and eventually controlled. chicken that are 6 weeks old; or an infection caused 1.3. At properties that maintain poultry for by an Influenza A virus of subtype H5 or H7, with a commercialization or for raising, at backyard sequence of nucleotides that present multiple basis flocks and other poultry lodging locations for the of aminoacids in the cleavage area of the hemoag- ones kept in captivity. glutinin ((Manual Standards of Diagnostics Test and Vaccines OIE, chapter 2.1.14 year 1996; OIE Interna- CHAPTER II tional Zoosanitary Code, 2001).

DISEASES CHAPTER III

1. THE NEWCASTLE DISEASE: is an infectious DEFINITIONS 222 poultry disease caused by a virus from the Para- mixovirus family, aviary Rubulavirus type of sero- 1. For the purpose of these rules, it is un- type 1 (APMV1), representing one of the following derstood: criterions of virulence: 1.1. OIE: World Organization for Animal • the virus has a pathogenicity index inside Health; the brain of at least 0.7 on Day-old birds (Gallus 1.2. MAPA: Ministry of Agriculture, Livestock gallus); or and Food Supply; • the presence of multiple basic amino acids 1.3. SDA: Animal and Plant Health and In- is shown in the virus (directly or by deduction), spection Secretariat; in the C-terminal fraction of the F2 protein, or 1.4. DDA: Animal Health and Inspection De- the same as the presence of phenylalanine in the partment; 117 residue, which is the N-terminal fraction of 1.5. CLA: Animal Laboratory Coordinating the F1 protein. The term “multiple basic amino Unit; acids”, refers to at least three arginine or lysine 1.6. CPS: Surveillance and Health Program residue, between residues 113 and 116. Coordination; In this definition, the amino acid residues 1.7. PNSA: National Avian Health Program; are numbered from the N-terminal fraction of 1.8. DIPOA: Department of Inspection of the amino acid sequence deducted from the nu- Animal Origin Products; cleotide sequence of the gene. F0 and residues 1.9. DFA: Federal Agricultural Delegacy; 1.10. SSA: Animal Health Service; by distinctive personnel and other employees; 1.11. SIF: Federal Inspection Service; 1.25. MONITORING OF FLOCKS: is the labo- 1.12. OFfICIAL SERVICE: is the federal, state, ratory health and analysis follow up, by means and municipal animal health protection service; of serological tests and other by other means, on 1.13. OFFICIAL LABORATORIES: are the labo- other biological material or not, and epidemio- ratories from the MAPA chain; logical analysis of the health conditions of poul- 1.14. ACCREDITED LABORATORIES: are the try lodged in an poultry holding and adequate laboratories of other federal, state, municipal, or interpretation of the results; private institutions, that have been approved and 1.26. COMMERCIAL BIRDS: generation of recognized by the MAPA, to perform laboratory di- poultry used for producing meats, eggs, deriva- agnosis of disease agents referred by these rules; tives and subproducts; 1.15. FEDERAL INSPECTOR: is a MAPA inspec- 1.27. SUSCEPTIBLE POULTRY: involves all do- tor with veterinary qualifications that inspects mestic, wild, exotic and ornamental birds; and supervises matters regarding animal health 1.28. INFECTED POULTRY: is any poultry protection; which has been officially tested positive for the 1.16. OFFICIAL VETERINARIAN: is the Federal Newcastle disease or avian influenza through Inspector with veterinary qualifications or the of- conclusive laboratory proof; ficial veterinarian of the official animal health 1.29. LIVESTOCK PRODUCT: includes meat, protection service; eggs, legs, blood, bowels and bones from the sus- 1.17. ACCREDITED VETERINARIAN: is the offi- ceptible animal; cial, state, municipal, private, or an independent 1.30. POULTRY MEAT: it is poultry meat, professional veterinarian, whom received delega- muscular eatable part of the slaughtered birds, tion of competence of the federal official service declared proper for human consumption by an to issue the Animal Movement Permit (GTA) or official veterinary inspection performed before similar; and after the slaughter; 1.18. TECHNICIAN IN CHARGE: is the veteri- 1.31. CARCASS: is the full body of a poultry narian responsible for the hygenic/health control after numbness or not, bleeding, plucking and at the flocks of the poultry farming premises, evisceration, in which craw, trachea, esophagus, properly registered at the MAPA; intestines, cloacal, spleen, reproductive organs 1.19. HEALTH CERTIFICATES: are health in- and lungs have been removed. he extraction of 223 spection certificates; kidneys, feet, neck and head is optional; 1.20.ANIMAL MOVEMENT PERMIT (GTA): is 1.32. SUBPRODUCTS: meat, blood, leg and the mandatory document used for the transit of bowel meal; incubation residues; litter; skin; poultry, hatching eggs and 1 (one) day old poul- feather and plume; and phaners; try, any type of handling and objective; 1.33. VEHICLE: any type of transportation on 1.21. FORM IN: is the standard DDA form, ground, water or air; used for opening the outbreaks and to perform 1.34. OUTBREAK: is the establishment in an epidemiological investigation; which the presence of the Newcastle disease or 1.22. FORM COM: is the standard DDA inves- avian influenza has affected one or more birds; tigation supplement form; 1.35. PERIFOCAL AREA: is the area around 1.23. STATES OF THE PROGRAM: are the the outbreak, which limits are established by the states named by the DDA, that develop health official service; monitoring operations for the PNSA diseases and 1.36.PROTECTION ZONE: ie the area of 3 the permanent epidemiological surveillance for (three) km radius around the outbreak, consid- aviary diseases; ered as the infected zone; 1.24. EPIDEMIOLOGICAL UNIT: it is a unit of 1.37.SURVEILLANCE ZONE: is the area of the poultry holding that allows the poultry that 7 (seven) km radius from the protection zone are lodged there to be treated and fed separately around the outbreak; 1.38. PROTECTION ZONE + SURVEILLANCE 1.49. CENTER: is the unit with an area ad- ZONE: 10 (ten) km radius around the outbreak; equately isolated, of common handling, consti- 1.39. DOWNTIME: is the period of which the tuted of one or more barns. lodging of an poultry holding is emptied out after 1.50. BATCH: group of poultry for the the occurrence of an infestation, eliminating all same purpose, origin and age, lodged in one birds and washing and disinfecting the barn; or many barns. 1.40. SACRIFICE: is the slaughter of all dis- 1.51. BOXES: are physical sections divided eased birds with signs of contamination or re- inside a barn. lated to the matter of biosafety, its direct and indirect contacts; CHAPTER IV 1.41. DESTRUCTION: elimination of poultry, its products, subproducts, meat or carcass, PROCEDURES THAT MUST BE COMPLIED by any physical or chemical means that assures BY POULTRY HOLDINGS total inactivation of the Newcastle and avian influenza viruses; 1. To attend to the PNSA, poultry holdings of 1.42. EMERGENCY VACCINATION: is the vac- permanent and eventual controls must: cination applied as means of controlling the 1.1. Be registered at the DFA, or registered in disease after one or more cases have been reg- the cases established by the MAPA in the official istered, or when the epidemiological or health service of the state in which they are located; situation require; 1.2. Be under the surveillance and control of 1.43. OWNER: all those who are depositary, the SSA/DFA, or of the State Secretariat of Agri- or by any means , maintains in their possession culture, or the department that issued this docu- one or more susceptible birds; ment, in the state which they are located; 1.44. PROPERTY: location where birds are 1.3. In the cases defined by the MAPA legisla- lodged for commercialization or not (e.g.: estab- tion, they must be supervised by a veterinarian, lishment where birds are lodged, for leisure or the vererinarian in charge, registered at the DFA, domestic breeding, and commercial stores); or of State Secretariat of Agriculture, or by the de- 1.45. POULTRY HOLDING: is the location partment that issued this document, in the state where poultry is kept for any purpose, which may which they are located, when the responsibility be constituted of one or more centers. is passed over; 224 1.46. POULTRY HOLDING PERMANENTLY 1.4. Proceed with the notification to the CONTROLLED: they are the farms, genetically se- health authorities of any probable signs of the lected, of primary breeders (pure breeds), great Newcastle or avian influenza diseases; grandparent farms, grandparent farms, head of- 1.5. Use only immunogens, disinfectants, fice farms, farms of breeding poultry free of spe- antigens, control serums, and “kits” registered at cific pathogens (SPF), and the hatcheries of these the MAPA, observing the starting number, name establishments. of the manufacturer, and expiration date. 1.47. POULTRY HOLDING EVENTUALLY CON- TROLLED: they are the poultry holdings producing CHAPTER V commercial eggs, poultry for slaughter, exploring other wild birds, or ornamental, and/or exotic or NOTIFICATION not, and the hatcheries of these establishments. 1.48. BARN: is the aviary production unit, 1. The veterinarians, owner, or any other characterized as the unit of a center, which lodg- person aware of the occurrence or suspiscion of es a group of breeders, poultry for slaughter or Newcastle disease and avian influenza, are en- commercial laying hens, of the same age (with forced to communicate the occurrence immedi- exception of pure breeds, genetically selected), ately to the official service (Decree No.24.548, of and of the same breed. July 3, 1934, and Ministerial Administrative Rul- ing No.070/94, of March 3, 1994). tion of the following measures of animal health 1.1. The notification may be done person- protection: ally, by telephone, radio, fax, e-mail or any other 2.1. Notification of suspicious signs of the available way. Newcastle disease and avian influenza; 2. The infraction as per item 1 will be investi- 2.2. Assistance to the outbreaks; gated by the official service that will use available 2.3. Adopting biosafety measures; measure to investigate responsibilities. 2.4. Applying measures of disinfection; 2.1. In the case of a veterinarian, besides 2.5. Sacrifice; what is mentioned or as per item 2, the official 2.6. Downtime; service must proceed according to the specific 2.7.Epidemiological analysis; professional legislation. 2.8. Routine or emergency vaccination at 3. The official service must be notified of flocks; the probable signs, preferably through the local 2.9. Control and inspection of susceptible veterinarian service, and sent to the an official animals; laboratory or to one accredited by the MAPA, for 2.10. Transit control; this matter, from any lesion caused by the disease 2.11. Other health measures. that should be found during the inspection, the slaughtering or during the necropsy. CHAPTER VII 4. At the slaughterhouses, in cases of signs of the disease(s), the slaughtering must be sus- ASSISTANCE TO THE OUTBREAKS pended until the conclusion of the cleanup and disinfection as recommended according to the 1. SUSPICION: criterions established by the DIPOA, and immedi- 1.1. All suspicion and occurrence notifica- ately communicated to the official service. tions for the Newcastle disease and avian influenza, the second is considered exotic at industrial CHAPTER VI poultry flocks of the country, must be immediately investigated by the official service follow- OPERATION STRATEGIES ing the rules of health protection, sending the samples to the an official laboratory, or to one 1. Monitoring of the Newcastle disease and accredited by the MAPA, for this matter. 225 avian influenza, and control and eradication 1.2. The notification of the probable signs of of the Newcastle diseases will be applied in all these diseases will include adopting the following states of the country. health measures: 1.1. Since the avian influenza is considered an 1.2.1. Interdiction of the aviary property or exotic disease at industrial poultry flocks in Brazil, premises, opening of the FORM IN, and adoption the risk of entry must be evaluated in the country, of specific health measures with immediate col- and permanent surveillance must be kept. lection of samples to be sent to a laboratory of 1.2. Because of the economical importance the official network or when authorized by the of the aviculture and of the epidemiological MAPA, for accredited laboratory , for this matter, characteristics, a study on viral activity will be along with a copy of the FORM IN; performed with the implementation of a New- 1.2.2. Registration of all categories of poultry castle disease free zone in the industrial produc- indicating the number of dead birds, with and with- tion area of the country, and the surveillance for out clinical sign(s) of the disease(s) by category; the Newcastle disease and avian influenza in the 1.2.3. Poultry maintenance at lodging, or states will be considered priority by the PNSA/ other confinement nucleis established by the DDA/SDA/MAPA. federal inspector or by the official veterinarian, 2. The prophylaxis, the control and the erad- where they can remain isolated and the move- ication of these diseases consist in the applica- ment prohibited; 1.2.4. Control by the federal inspector or by cal evaluation and health risk may be applied the official veterinarian, of any transit of people, at other poultry holdings if instructed to do so animals, vehicles, meats, carcasses, debris, excre- by the official service; ment, litter, fomites and structures that might 2.1.9. The official service will proceed with propagate the disease(s); the epidemiological investigation at all prop- 1.2.5. Utilization of adequate means to disin- erties with poultry, poultry holdings and other fect roads and exits of each aviary lodging premis- lodging locations, protection zone, constituted es, according to the recommendations of the OIE; in a 3 (three) km radius and a 7 (seven) km 1.2.6. Conducting the epidemiological inves- radius around the outbreak, from the protec- tigation with the opening of FORM IN, and later tion zone (surveillance zone), determined with of FORM COM, to determine the origin of the in- basis on fact of geographical, administrative, fection and its propagation; ecological and epizootiological origin related 1.2.7. Abduction of the poultry meat and to the disease, registering all visits and stated the eggs produced in the period of incubation occurrences; of the diseases. 2.1.10. The official service will establish the 2. CONFIRMATION: prohibition of transit and taking the poultry off 2.1. With the confirmation from the labora- the poultry holdings, within the surveillance tory diagnosis of the Newcastle or avian influ- zone, for the minimum period of 21 (twenty enza diseases, defined in Chapter II, of this rule, one) days, except for those for sanitary slaugh- by conclusive laboratory exams, at the property ter, preferably at slaughterhouses with the SIF, where the outbreak was identified, the federal in- located within the surveillance zone, designated spector or the official veterinarian will adopt the and supervised by the federal inspector or offi- following measures: cial veterinarian. 2.1.1. Immediate sacrifice at the location of 3. The location in which the abducted mate- all the poultry from the poultry holdings; rial is located will be cleaned and disinfected, and 2.1.2. Destruction of all poultry that have products and sub products will be destroyed. died or have been sacrificed; 4. PROTECTION ZONE: 2.1.3. Destruction or appropriate treatment 4.1.Measures must be adopted regarding the of all residues, such as: feed, litter and feces, protection zone, as follows: and susceptible fomites of being contaminated; 4.1.1. Immediate visit by the official service 226 2.1.3.1. The treatment must be conducted and future monitoring of all properties with in agreement with the instructions of the federal poultry, poultry holdings and poultry lodging inspector or the official veterinarian, in a way to locations, performing clinical evaluation on the assure the destruction of the viruses of Newcastle lodged birds, and collection of samples for labo- disease and avian influenza. ratory examinations, registering all visits and oc- 2.1.4. Destruction of the meat of all poultry currences; originated from the farm and sacrificed during 4.1.2. Maintenance of all poultry in their the period of the incubation of the disease; lodge or any other location that allows isolation, 2.1.5. Destruction of the eggs and sub prod- at the choice of the official service; ucts that were produced during the probable pe- 4.1.3. Utilization of appropriate disinfection riod of disease incubation; systems according to the criterions of the official 2.1.6. Cleanup and complete disinfection of service at port of entries and exits of the property the breeding nuclei; or poultry holding; 2.1.7. Establish the downtime of at least 21 4.1.4. The official service will proceed with (twenty one) days before reintroducing poultry the transit control within this zone, of people, of into the poultry holding, initiated after the disin- material, equipment and vehicles that represent fection process is complete; a health risk; 2.1.8. The measures for the epidemiologi- 4.1.5. The official service will prohibit the transit and removal of poultry, eggs, manure, 4.1.12. The measures applied in the zone of feed, sub products of poultry, fomites of the protection will be kept until the laboratory diag- property or of the poultry holding in which they nosis is concluded, and the epidemiological inves- are found, except with the authorization of the tigation, for at least 21 (twenty one) days after the official service in charge of transportation, in the result, at the infected property or poultry holding, following conditions: of the preliminary cleaning and disinfecting op- 4.1.5.1. Poultry for slaughter ,preferably at erations, or by determination of the official ser- a slaughterhouse with the SIF, located at the in- vice. After these measures, the protection zone fected area or, if that is not possible it must be will then be part of the surveillance zone. performed at an evaluated location, designated 5.SURVEILLANCE ZONE: and supervised by the federal inspector or by the 5.1.Measures must be adopted regarding the official veterinarian; surveillance zone, as follows: 4.1.5.2. Day-old birds or birds for a property 5.1.1. Investigation on all properties with located inside the surveillance zone and which poultry, poultry holdings and poultry lodging does not contain other lodged birds; locations, in a 10 (ten) km radius, registering all 4.1.5.3. The eggs for hatching and for birth in visits and occurrences; a hatchery within the protection or surveillance 5.1.2. Prohibition by the official service of zones previously designated by the federal in- poultry and egg movement within the zone, in spector or by the official veterinarian, controlled the first 15 (fifteen) days; and performed in separate machines. 5.1.3. Maintenance of all poultry in their 4.1.5.3.1. The eggs and their packages must lodges or any other location that allows isolation, be disinfected before transferring them to the at the choice of the official service; hatchery. 5.1.4. Prohibition by the official service of 4.1.6. The previously mentioned movements the movement and removal of poultry from the must be performed directly under the control property or poultry holding within the surveil- of the official service and authorized after the lance zone, except the ones intended for slaugh- health inspection on the property or poultry ter, preferably at a slaughterhouse with SIF, lo- holding, performed by a federal inspector or by cated within the surveillance zone or nearby, an official veterinarian; analyzed and designated by the federal inspector 4.1.7. The means of transportation being ap- or by the official veterinarian; 227 plied must be cleaned and disinfected before and 5.1.5. Prohibition by the official service to re- after its usage; move eggs from the surveillance zone, except if 4.1.8. The poultry manure withdrawn from sent to a hatchery for incubation and birth, evalu- the feed and the poultry sub products is subject ated and designated by the federal inspector or by to the control by the official service as to trans- the official veterinarian, with controlled incuba- portation and destination, after substantial eval- tion and performed in separate machines; uation, and is no longer represents a dissemina- 5.1.5.1.The eggs and their packages must tion risk of the disease(s); be disinfected before transferring them to the 4.1.9. The official service will prohibit fairs, mar- hatchery. kets, exhibitions and any other poultry gatherings; 5.1.6. Prohibition for removing and using 4.1.10. The official service will proceed with the manure, feed and poultry sub products with- the introduction of sentinel poultry onto the de- out an authorization of the official service; populated outbreak property; 5.1.7. The official service will prohibit 4.1.11. The official service will establish the se- fairs, markets, exhibitions and any other poul- rological control at official or MAPA accredited labo- try gatherings; ratories for this matter, every seven days on sentinel 5.1.8. The official service will proceed poultry until the period of downtime is complete, with the transit control within this zone, of with the minimum of 21 (twenty one) days; people, of material, equipment and vehicles that represent a health risk; 2. Samples 5.2. The measure applied to the surveillance 2.1. For isolation and identification of the vi- zone will be maintained until the conclusion of rus, samples must be collected from live poultry the laboratory diagnosis and of the epidemio- after the necropsy of the sacrificed poultry, or of logical investigation for at least 30 (thirty) days, the ones which died with clinical symptoms sug- determined by the official service, after prelimi- gesting the Newcastle disease or avian influenza. nary cleaning and disinfection operations of the 2.1.1. Live poultry: infected holding;. 2.1.1.1. Serum; 6. The operations described in this chapter 2.1.1.2. Cloacal swab: may circumscribe the areas of the establish- 2.1.1.3. Tracheal swab: ment which create an epidemiological unit; as 2.1.1.4. Fresh feces. long as the official service guarantees that the 2.1.2. Necropsy poultry (collect aseptically, disease(s) will not spread to the other non in- isolated or in “pool”): fected units. 2.1.2.1. Spleen; 2.1.2.2. Brain; CHAPTER VIII 2.1.2.3. Heart; 2.1.2.4. Faeces; COLLECTING SAMPLES AND FORWARDING 2.1.2.5. Liver; THEM FOR LABORATORY TESTING 2.1.2.6. Aqueous humour; 2.1.2.7. Bowel; 1. Location and events where the collection 2.1.2.8. Proventriculus; of the material is performed: 2.1.2.9. Lung / trachea; 1.1. Of poultry originated from any country, 2.1.2.10. Air sacs; at the port of entry (port, airport or border), in 2.1.2.11. Oronasal swab; quarantine, at the time of the veterinary inspec- 2.1.2.12. Cecal tonsils. tion for the entry discharge; 2.2. In a suspected case, focusing on reduc- 1.2. In suspiscion of an outbreak by the of- ing the risk of dissemination and diffusion of the ficial service; virus(es) of the disease(s) during the transporta- 1.3. Performing the study project of virus tion to the laboratory, it is recommended to per- activity, with focus on applying the free zone form the necropsy at the location, with collec- 228 for the Newcastle disease within the area of in- tion of the material and adequate storage to be dustry production in the country, and surveil- sent to an official laboratory, or to a laboratory lance for the Newcastle disease and avian in- designated by the MAPA. fluenza, for the monitoring of domestic flocks 3. Collection and storage of samples by the official service of animal health and 3.1. They must be collected in PBS, pH 7.2, inspection, within the areas of competence. containing antibiotics in the concentrations of:

ANTIBIOTICS SAMPLE (p/ml of PBS) SWABS FAECES ORGANS

Trachea Cloacal Penicillin 2000 IU 10000 IU 10000 IU 2000 IU

Etreptomycin 2 mg 10 mg 10 mg 2 mg

Gentamicin 50 μg 250 μg 250 μg 50 μg

Fungizone 1000 IU 5000 IU 5000 IU 1000 IU 3.2. Properly identified, refrigerated, sealed 1.4. Intracerebral pathogenicity index and stored in isothermal boxes; (ICPI); 3.3. Forwarded with FORM IN or a standard 1.5. Intravenous pathogenicity index (IVPI); DDA collection form, properly filled out; 1.6. Agar gel Immunodifusion (AGID); 3.4. They will be registered at official or 1.7. Molecular biology techniques. MAPA accredited laboratories for this matter, on 2. Other exams will only be considered when a proper book, according to the model indicated approved by the PNSA/CPS/DDA/SDA. by the CLA/DDA/SDA/MAPA; 3. Only laboratory exams related to the 3.5. When being sent to the serology, they diagnosis of the diseases standardized by the must be refrigerated or preferably frozen. Blood MAPA will be accepted, performed at official samples with signs of clots will not be accepted; or MAPA accredited laboratories for this mat- 3.6. When received, they must be divided in ter, and confirmed by the Laboratory of Na- 2 (two) pieces and identified, one as sample and tional Reference. the other as confirmaton sample; 4. All professionals and laboratories perform- 3.7. The identification tag of the confirmaton ing diagnosis on aviary diseases are obligated to sample, according to the model indicated by the immediately notify the suspiscion or occurrences CLA/DDA/SDA/MAPA, will be fill out and sealed of the Newcastle diseases and avian influenza. along with the confirmaton samples; the seal will 5. All the material for laboratory examina- be of plastic material, numbered and secured. tions must be sent along with the FORM IN or by 3.8. On the specific cases of study project of a standard DDA/SDA/MAPA collection form, fill the virus activity of the Newcastle disease and of out correctly, signed by the federal inspector or surveillance of the Newcastle disease and avian by the official veterinarian, or even by the per- influenza, items 3.6 and 3.7 are not applied. son responsible for the collection endorsed by 4. Conservation and stocking the official service. 4.1. The samples that are intended for the vi- 5.1. At the port of entry, the standard MAPA rological exams must be kept under refrigeration, material importation form will be used. preferably frozen until its processing. 5.2. During the study project of viral activity of 4.2. The samples intended for the serology the Newcastle disease, and the surveillance of the must be kept frozen at –20ºC, until its processing. Newcastle disease and avian influenza, a standard 4.3. After the result has been issued, the DDA/SDA/MAPA collection form will be used. 229 samples must be kept frozen at –20ºC, for at least 5.3. In the case of probable signs as to an 30 (thirty) days. outbreak, the FORM IN will be used.

CHAPTER IX CHAPTER X

LABORATORY DIAGNOSIS THE FORWARDING OF LABORATORY RESULTS 1. The laboratory procedures and exams for the diagnosis of the Newcastle disease and avian 1. The laboratory test results must be issued influenza, are determined by strict rules of the on a standard MAPA form, and communications SDA/MAPA, with the possibility of performing the according to the flowchart established: following exams: 1.1.Negative result: send FAX or other type 1.1. Enzyme Linked Immunosorbent As- of immediate notification to the DDA/SDA/MAPA, say (ELISA); and to the SSA/DFA/MAPA of the state in which 1.2. Hemagglutination test (HA); the establishment is located; 1.2. Hemagglutination inhibition test (HI); 1.2.Positive result: send FAX or other type of 1.3. Estimated time for the death of the immediatre notification to the DDA/SDA/MAPA, embryo (TMM); which will notify the SSA/DFA/MAPA. CHAPTER XI be serological, isolation and virus characterization tests; THE STUDY FOR VIRUS ACTIVITY OF THE 3.5. The activities regarding samples collec- NEWCASTLE DISEASE AND SURVEILLANCE tion may be performed by the SSA, SIF of the DFA/ FOR THE NEWCASTLE DISEASE AND MAPA, or by the State Departments of Agricul- AVIAN INFLUENZA ture, or by the ones responsible for these activities, when this activity is authorized in agreement 1. Prophylactic activities will be performed, with this project. with focus on controlling entries of possible exotic 3.6. The serological exams in this project will disease agents into domestic territory such as avian be defined in the scope of the DDA/SDA/MAPA, as influenza, during the permanent epidemiological per the correlation between them. and health surveillance of the Newcastle disease: 3.7. The collections for monitoring and for 1.1. During the unloading process at the port diagnosis, will only be accepted when performed of entry, during the health inspection of the ge- by the federal inspector or by an official veteri- netic material (of poultry or hatching eggs), by narian, or under their supervision. the airport surveillance service (SVA/DFA/MAPA); 3.8. The sampling, period of collection, se- 1.2. During the official quarantine or the rological tests, the analyses criterions related to incubation of the hatching eggs, by the official vaccinated and non-vaccinated poultry and the service. interpretation of the results will be defined in the 2. The material collected from the day-old referred project. bird, hatching eggs or cloacal and tracheal swabs 4. The laboratory exams will be performed from any country, will be forwarded to an official by the MAPA official laboratory, of national refer- laboratory in a package sealed by the MAPA, to ence to these diseases, and may be performed at perform the laboratory examinations and iden- federal or state institution laboratories, or when tify the disease agents, along with the standard authorized by the CLA/DDA/SDA/MAPA. collection form. 5. The epidemiological analysis will be per- 3. The study project of virus activity for the formed according to the information established Newcastle disease, and the surveillance for the by the DDA/SDA/MAPA. Newcastle disease and avian influenza, for the 6. The result evaluations will be nationally monitoring of the domestic avian flocks through- performed at the DDA/SDA/MAPA. 230 out different states will be introduced by the DDA/ SDA/MAPA, observing the status of epidemiologi- CHAPTER XII cal diseases, considering the exotic disease status for avian influenza at industrial Brazilian flocks: CLEANING AND DISINFECTING MEASURES 3.1. Initially it will be applied in the production area, with the possibility of being applied to 1. The cleaning and disinfecting measures other production systems according to the proj- used for the control of outbreaks, will proceed ect evaluation, and by the determination of the with the criterions established on the OIE manu- DDA/SDA/MAPA. al, and in specific manuals of the PNSA/CPS/DDA/ 3.2. The states participating in the project SDA/MAPA. will be defined by the DDA/SDA/MAPA. 3.3. The periodic collections of blood serum, CHAPTER XIII tracheal and cloacal swabs form the poultry of the same batch at slaughterhouses with SIF, with VACCINATION the possibility of collections at poultry holdings determined by the PNSA/CPS/DDA/SDA/MAPA, ac- 1. Systematic vaccination against Newcastle cording to this project. disease is optional throughout the states, as per 3.4. The laboratory exams performed will the local epidemiological status. 2. According to the epidemiological status 2. Poultry will be prohibited for transit of each region, after evaluation by the official when unaccompanied of the GTA, issued as per service, poultry vaccination against Newcastle these rules, the responsible authority must fill in disease may be enforced on properties and per- the Term of Incident, and determine the return manently or eventually controlled poultry hold- to the origin, without prejudice to the appropri- ings, or also performed regularly. ate sanctions. 3. It is responsibility of the official service 3. To perform interstate transit, it is de- during emergency situations to establish vacci- manded that the GTA be used. For intrastate nation schedules per area. transit, it is demanded that the GTA be used, be- 4. Vaccination against these diseases will ing able to be used in exceptional cases that are only be performed with registered and MAPA justified, to the acceptance of the similar transit approved vaccines (Decree No.1.662, of October document established in the state scope. 6, 1995, and Ministerial Administrative Ruling 4. The vehicles for the transportation of No.186, of May 13, 1997), as a measure of pro- susceptible poultry must be washed and dis- phylactic order or control of the disease. infected according to the orientation of the 5. In the case of avian influenza, since it official service. is considered an exotic disease in the country, 5. The transportation of poultry residues, vaccination can only be performed when autho- sub products must be done in vehicles that are rized by the DDA/SDA after confirmation of the protected or closed. disease, risk evaluation and analysis of the epidemiological status. CHAPTER XV

CHAPTER XIV INCUBATION CONTROL

TRANSIT 1. Biosafety measures on the incubation, when determined by the official service: 1. With intensions of avoiding the intro- 1.1. The egg incubation must meet to carry duction and the spreading of these diseases, out the provisions in Chapter VII, of this term, at the time of issuing the GTA for susceptible respecting the natural agreements in the control poultry, or for interstate transit of poultry for of the protection and surveillance zones; 231 slaughter at slaughterhouses, must be de- It is forbidden to incubate hatching eggs manded by the issuer, among others, the fol- from great grandparent, grandparent and par- lowing conditions: ent hatchers, and in the same period, meeting 1.1. At poultry holdings providers for inter- all health criterions of the superior breed. national market: 1.2. Birds must be from a property or poul- CHAPTER XVI try holding which have not had any signs of infection of Newcastle disease and avian influenza GENERAL DISPOSITIONS for the last 90 (ninety) days, and that the surroundings within a 10 (ten) km radius, has not The SSA/DFA/MAPA of the State in which the been infected by these diseases in the past 30 poultry holding is located, and the State Depart- (thirty) days; ments of Agriculture, are the responsible and 1.3. Based on local epidemiological situation competent offices for defining appropriate mea- and Chapter XIII of this rule, the requirements for sures for handling health issues, as per the estab- transit of susceptible poultry in locations consid- lished in the Animal Health Protection Regula- ered of risk, must prove that they were not vac- tion and in the PNSA. cinated against the Newcastle disease for at least 2. In consideration to the characteristics 30 (thirty) days prior to the slaughter. of a health emergency in the occurrence of an outbreak of Newcastle disease or avian in- allantoids liquid diluted at 1:10, bacteria free; fluenza, and the need of the official service 3.2. Any H5 or H7 influenza virus that does to apply measures of immediate eradication, not meet the criterion of the previous item, the establishments that produce poultry free however that has a sequence of amino acids of specific pathogens (SPF), must provide 10 (in the cleavage site of the hemagglutinin), birds to be used as sentinel upon official so- that is compatible with the highly pathogenic- licitation, for evaluation and closure of the ity influenza virus; outbreak . 3.3 Any influenza virus that is not H5 or H7, 3. Since the avian influenza is considered that kills 1 to 5 times (pathogenicity), and grows an exotic disease in the industrial domestic avi- in a cell culture in the absence of trypsin. an flock, they must be observed, investigated 3.4. After careful evaluation by the official and evaluated at a laboratory, and epidemio- service and by the PNSA/CPS/DDA/SDA/MAPA, logically by the official service, additionally as health measures that are relevant to the case described in item 2, of Chapter II, in these rules, will be applied. for the following situations: 4. The omissive cases and the questions 3.1. Any influenza virus that is lethal to 6,7 created in the application of this rule, and and 8 susceptible 4-6 week old birds, 10 days af- in complementary acts will be voided by the ter intravenous inoculation with 0,2 ml of cornea- DDA/SDA/MAPA.

NORMATIVE INSTRUCTION No.44 OF AUGUST 23, 2001

Published in the Official Gazette of August 28, 2001, Section 1, Page 68

Approves the Technical Rules for the Control and the Certification of Aviary Centers and Establishment for the Aviary Mycoplasmosis (Mycoplasma gallisepticum, synoviae and melleagridis).

THE SECRETARY OF ANIMAL AND PLANT Art. 1. To approve the Technical Rules for 232 HEALTH AND INSPECTION OF THE MINISTRY OF the Control and the Certification of Aviary Centers LIVESTOCK AND FOOD SUPPLY, using the powers and Establishment for the Aviary Mycoplasmosis invested in him in article 83, clause IV, of the (Mycoplasma gallisepticum, synoviae and mellea- Internal Regulation of the Secretariat, approved gridis), according to the annex of this Normative by Ministerial Administrative Ruling Nº.574, of Instruction. December 8, 1998, in consideration and in light Art. 2. Revoke the SDA Normative Instruc- of the provisions of the Ministerial Administrative tion Nº.13, of June 29, 1999. Ruling No.193, of September 19, 1994, and in File Art. 3. This Normative Instruction will be in MA 21000.005233/2001-68, decide: effect on the date of its publication.

LUIZ CARLOS DE OLIVEIRA ANNEX

TECHNICAL RULES FOR THE CONTROL AND CERTIFICATION OF AVIARY CENTERS AND ESTABLISH- MENTS FOR AVIARY MYCOPLASMOSIS (Mycoplasma gallisepticum, synoviae and melleagridis).

CHAPTER I lected), and of the same breed. 1.4. Commercial poultry: generation of INTRODUCTION poultry meant for slaughter and/or egg production for consumption. 1. These rules define the measures of moni- 1.5. Center of breeding: is the unit with an toring salmonellosis in poultry holdings perma- area adequately isolated, of common handling, nently and eventually controlled (except layers, constituted of one or more barns. poultry for slaughter and ratites), that perform 1.6. Poultry holding: is the location where the commercial, or domestic and international poultry is kept for any purpose, which may be transference of derived products, intended for constituted of one or more centers. breeding and for the production of poultry and 1.6.1. Poultry holding Permanently Controlled: hatching eggs, having to perform monitoring of they are the farms, genetically selected, of primary their plants, obeying the directions of the Na- breeders (pure breeds), great grandparent farms, tional Avian Health Program (PNSA). grandparent farms, parents farms, breeding poul- 2. To operate in the international market, try free of specific pathogens (SPF) farms, and the the poultry holding must be certified as free for hatcheries of these establishments. aviary mycoplasmosis (Mycoplasma gallisepti- 1.6.2. Poultry holdings controlled eventu- cum, Mycoplasma synoviae and Mycoplasma ally: they are the poultry holdings producing melleagridis), as established in Chapter IV of commercial eggs, poultry for slaughter, exploring this annex. other wild birds, or ornamental, and/or exotic, 3. The importing businesses or purchasers of and the hatcheries of these establishments. genetic material of pure breeds, great grandpar- 1.7. Official service: Federal, State, and Mu- ents and grandparents, must present the guar- nicipal Animal Health and Inspection Service. antee or certification as to free of the constant 1.8. Official laboratories: are the laborato- mycoplasmas in these rules. ries of the Ministry of Agriculture, Livestock and 233 Food Supply (MAPA). CHAPTER II 1.9. Accredited laboratories: federal, state, municipal or private laboratory units, qualified DEFINITIONS and recognized by the MAPA, to perform laboratory diagnosis of disease agents to which these 1. For the purpose of these rules, it is un- rules refer to. derstood: 1.10. Federal Inspector or Official Veteri- 1.1. Batch: group of poultry for the same narian: professional veterinarian of the Federal purpose, origin and age, lodged in one or many Public Service, who performs activites of Animal barns. Health and Inspection. 1.2. Boxes: are physical sections divided in- 1.11. Official Veterinarian: Federal Inspector side a barn. or Veterinarian of the Federal Public Service. 1.3. Barn: is the aviary production unit, 1.12. Official Veterinarian for Certification: characterized as the unit of a center, which Federal Inspector or Official Veterinarian of the lodges a group of breeders, poultry for slaugh- Animal Health and Inspection Service. ter or commercial laying hens, of the same age 1.13. Official Accredited Veterinarian: Vet- (with exception of pure breeds, genetically se- erinarian of the state, district, private sector or independent professional, with authorization of fere in the results of serological tests, and/or in- jurisdiction of the federal official service , to issue terfere with the isolation of the salmonellas in a the Animal Movement Permit – GTA. period of three weeks prior to the tests; 1.14. Responsible Technician: Veterinarian 2.4. the exceptional cases must be evaluat- responsible for the sanitary control of the flocks ed by the DDA/SDA, as long as it is presented and of the aviary centers or premises. approved by a specific technical-scientific project. 1.15. Monitoring of Flocks: is the sanitary 3. Only antigen, control serums and “kits” supervision of the serological tests and of other approved by the MAPA, can be used, as per the biological exams, as well as the epidemiological expiration date. analysis related to the health conditions of the 4. Other laboratory tests will only be able birds lodged at an aviary center or premises. to be used when properly approved by the PNSA. 1.16. MAPA : Ministry of Agri- 5. The poultry holding must provide monthly culture, Livestock and Food Supply a calendar of samplings, which will be forwarded 1.17. SDA : Animal and Plant Health to the DFA of the State where it is located, along and Inspection Secretariat with the schedules of birth, importation and 1.18. DDA : Animal Health and Inspection dates of routine sample collection performed by Department the technician in charge, focusing on the inspec- 1.19. CLA : Animal Laboratory Coordination tion and the supervision of the official service. Unit 1.20. PNSA : National Avian Health Program CHAPTER IV 1.21. DIPOA : Department of Inspection of Animal Origin Products. CERTIFICATION 1.22. DFA : Federal Agricultural Delegacy 1.23. SSA : Animal Health Service 1. Certification for the pure line, great grand- 1.24. SIF : Federal Inspection Service. parent and gradparent breeders centers or establishments . CHAPTER III 1.1. Free of Mycoplasma gallisepticum and Mycoplasma synoviae for chicken. DEMANDS 1.2. Free of Mycoplasma gallisepticum, My- coplasma synoviae and Mycoplasma melleagridis 234 1. To attend to the PNSA, poultry holdings of for turkey. permanent and eventual controls must: 2. Certification of the centers (parent breed- 1.1. Acquire registry and licensing at the ers establishments). DFA of the jurisdiction. 2.1. Free of Mycoplasma gallisepticum for 1.2. Be under the suveillance and control chicken. of the local Animal Health Service of the DFA or 2.2. Free of Mycoplasma gallisepticum, My- of the State Secretariat of Agriculture. coplasma synoviae and Mycoplasma melleagridis 1.3. Be supervised by the technician in for turkey. charge, registered at the Federal Agriculture Del- 2.3. Under supervision and monitoring of egacy of the State. Mycoplasma synoviae for chicken. 2. The poultry holding with participation of the PNSA will not be able to use: CHAPTER V 2.1. any vaccine for aviary mycoplasmosis at permanently controlled premises. LABORATORY TESTS 2.2. any vaccine prepared with oily adjuvant during the four weeks prior to the labora- 1. The tests used for laboratory monitor- tory tests; ing and diagnostic in the different stages of the 2.3. any drug scientifically proven to inter- process are: 1.1. Immunological diagnosis: tor, or by the official veterinarian. 1.1.1. Slow Serum Agglutination (SSA), or yolk 4. The official sampling must be performed from embryonated eggs. randomly among the barns in the same center 1.1.2. animal health and inspection. for serological tests, biological exams on SPF 1.1.3. Hemagglutination Inhibition, (HI). poultry, on embryonated eggs, or on mycoplas- 1.1.4. Enzyme Linked Immunosorbent As- mologic exams. say (ELISA) 5. With the focus on monitoring the health 1.2 Mycoplasmalogic diagnosis: status, certification maintenance and of regular 1.2.1. Isolation in culture medium. samplings at pure breed premises, great grand- 1.2.2. Polymerase Chain Reaction (PCR). parent and grandparent hatcheries, this stage 1.3. Identificaton of culture: must be performed directly by the federal inspec- 1.3.1. Indirect fluorescent antibody (IFA). tor, or by the official veterinarian, by random 1.3.2. Direct fluorescent antibody (DFA). double sample collections, at least once a year, 1.3.3. Metabolism inhibition (MI). being later forwarded for analysis at official or ac- 1.3.4. Growth inhibition (GI) credited laboratories. 1.3.5. Polymerase Chain Reaction (PCR). 6. DFA’s criteria as to the Animal Health 2. The completion and interpretation of the Service, and/or of the State Secretariat of Agri- tests mentioned above, will obey the criterions culture, of the State in which the poultry holding established in specific technical rules and regula- is located in, at any time and in the presence of tions of the MAPA. the federal inspector, or of an official veterinar- 3. The laboratory exams will only be ac- ian, random double samplings may be collected cepted when performed at an official labo- to be submitted for laboratory exams, respecting ratory, and/or accredited by the MAPA, iden- the criterions and rules of biosafety, at official or tifying the antigen, the lot number, and the MAPA accredited laboratories. amount used. 7. Material collected for official monitoring 4. Other laboratory exams may be used can be sent to any MAPA accredited laboratory as long as they are approved by the DDA/SDA/ for this matter, chosen by the federal inspector, MAPA. or by the official veterinarian responsible for the collection. . CHAPTER VI 8. MAPA will establish a system for the ran- 235 dom selection of samples and of official and ac- COLLECTION OF SAMPLES credited laboratories, which will be supervised by a federal inspector or by an official veterinarian 1. The collection of samples for official mon- responsible for the collection. itoring will only be accepted when performed by 9. The costs of official collections and of the a federal inspector, an official veterinarian, or un- shipping of this material to be analyzed by ac- der the supervision of one of them. credited laboratories will be at the expense of the 2. To receive certification, the samples will be requesting company. analyzed by the SSA/DFA of the State in which the 10. All the material officially collected must establishment is located, the samplings will be be sealed and sent along with a standard DDA/ forwarded by the company technician in charge SDA form. before the MAPA, and/or the random collection 11. Random samplings performed by the of- performed by the official service. ficial service may or not meet companies’ sched- 3. All material forwarded for laboratory ules, of which a federal inspector or an official testining must officially be forwarded with veterinarian are responsible for, and also respon- the standard DDA/SDA collection form, filled sible for collecting or supervising the process, and out correctly and signed by the technician in for securing the material, being of responsibility charge before the MAPA, by the federal inspec- of the company to provide the necessary means and materials for this operation. production, with posture of about 5%: 12. The same criterions used for parent 1.2.2.1. RSA on one hundred and fifty samples hatcheries will be applied for ornamental and per center, for Mycoplasma gallisepticum and one wild poultry. hundred for Mycoplasma synoviae for chicken. 1.2.2.2. RSA on one hundred and fifty sam- CHAPTER VII ples per center, for Mycoplasma gallisepticum and Mycoplasma melleagridis and one hundred PERFORMING LABORATORY TESTS for Mycoplasma synoviae for turkeys. 1.2.2.3. When result positive on HI or ELISA, 1. The procedure of laboratory tests per collect tracheal swabs from twenty birds for con- batch for the Certification of aviary centers or firmation per cultivation and/or PCR at accred- establishment free of Mycoplasma gallisepticum ited or official laboratory, chosen by the official and Mycoplasma synoviae for chickens, and My- animal health and inspection service. coplasma gallisepticum, Mycoplasma synoviae and 1.2.3. Establishment permanently controlled Mycoplasma melleagridis for turkeys, in light of (periodic control every three months). the provisions in Chapter IV, will be composed of: 1.2.3.1. RSA on ine hundred and fifty sam- 1.1. Poultry or hatching eggss from breeding ples per aviary center, randomly selected and and commercial breeding stock for restocking im- with the presentation of each barn and/or box ported aviary flocks: from the center, for Mycoplasma gallisepticum 1.1.1. The sample collection will be per- and Mycoplasma melleagridis, the last one ex- formed on arrival, and the laboratory tests per- cusively for turkeys, and one hundred samples formed as set forth to the specific rules for poultry for Mycoplasma synoviae, supplementary when and hatching eggss importation and exportation, as reagents, with HI and ELISA. The tests must intended for restocking aviary flocks. be permanently until it is totally eliminated from 1.1.1.1. When dealing with live or dead poul- the batch, allowing a variation of up to two weeks try, serological and/or mycoplasmologic tech- during the intervals, to confortably adapt blood niques will be used depending on the case. collecting to other handling procedures. 1.1.1.2. When dealing with eggs, yolk agglu- 1.2.3.2. When tested positive for HI or ELISA, tination from embryonated eggs and mycoplas- collect tracheal swabs and serum from twenty mologic exams may be used, birds for confirmation per cultivation and/or PCR 236 1.1.2. The poultry produced from pure at accredited or official laboratory, chosen by the breeds, and great grandparents in Brazil, will official service. follow the same procedure mentioned in item 1.2.4. Establishment eventually controlled, 1.1.1., having its first collection performed in the except commercial poultry, chicken for slaughter hatcheries at the moment of birth, by the SSA/ (periodic control every three months): DFA in the State where it is located, and sent to 1.2.4.1. RSA per center of one hundred and the official laboratory. fifty serum samples from poultry randomly se- 1.2. Health monitoring of aviary flocks lected and with presentation of each barn and/ 1.2.1. On 12 (twelve) week old breeding or box of the center for Mycoplasma gallisepticum stocks: and Mycoplasma melleagridis, according to Chap- 1.2.1.1. On chickens and turkeys: RSA of at ter IV of this rule, and one hundred samples for least three hundred samples for Mycoplasma Mycoplasma synoviae, confirmed by HI and ELISA gallisepticum and one hundred samples for My- when positive results were observed at RSA, and coplasma synoviae, selected randomly, with the repeated every three months until full elimina- presentation of each barn, and/or box per each tion from the batch, allowing a variation of about supplemented center, when concerning reagents two weeks to comfortably adapt the blood collec- with HI or ELISA. tion to other handling procedures. 1.2.2. On breeding stocks at the beginning of 1.2.4.2. On breeding stocks, where there is no possibility of using swabs, proceed to random- 2.2.2. The centers considered under surveil- ly collect from three birds within every thousand, lance and inspected for Mycoplasma synoviae as long as the minimum is ten and the maximum cannot be commercialized internationally, main- of twenty per center. taining production and incubation of the center 2. On other breeding stocks, the recommend- under surveillance and supervision until the final ed laboratory test is mycoplasmologic technique. productive cycle. 3. In cases of death during the first days of 2.2.3. The establishment considered under the batch, the poultry holding must forward ma- surveillance and control must reinforce measures terial from thirty rejected or agonizing birds to a of biosafety such as: official or MAPA accredited laboratory for isola- 2.2.3.1. To be protected by security fences tion of mycoplasmas or PCR. with one access only, with a wash and disinfecting system for vehicles. CHAPTER VIII 2.2.3.2. To have available criterions for the strict transit control, and of access to people (gates, INTEPRETATION OF THE RESULTS AND doors, receptions, concrete walls and other). ADOPTION OF BIOSECURITY AND 2.2.3.3. To have internal surfaces set up SANITARY MEASURES in a way that allows adequate cleaning and disinfection; 1. On poultry or hatching eggss from pure 2.2.3.4. To dispose of ways legally approved breeds, imported great grandparent and grand- by the MAPA, and by the departments of environ- parent breeders born in Brazil: mental control, for the destination of production 1.1. Positive for Mycoplasma gallisepticum, residues (dead poultry, manure, egg remains, Mycoplasma synoviae, sacrifice and destruction/ packaging, etc.) and others; sanitary slaughter of the center. 2.2.3.5. to isolate different age categories, 1.2. Positive for Mycoplasma gallisepticum, by fencing and /or by f non fruit-trees, with a re- Mycoplasma synoviae, Mycoplasma melleagridis, stricted single access, controlled flow, measures exclusive for turkeys, according to Chapter IV of biosecurity for the internal area, for vehicles, of this rule, sacrifice and destruction/sanitary personnel and material; slaughter at the center. 2.2.3.6. To allow the entrance of people, ve- 2. Parent Breeders: hicles, equipment and material in the internal 237 2.1. If tested positive for Mycoplasma gal- areas of the property, only when strict biosecurity lisepticum on chickens or Mycoplasma galisepti- measures are complied; cum, Mycoplasma synoviae or Mycoplasma mel- 2.2.3.7. Must apply control measures of liq- leagridis on turkeys, there will be sacrifice and uid effluents, by means of septic tanks, observing slaughter of all center, and the extinguishing of the distance of the water paths and groundwater, all eggs, hatched or not, originated there, accord- to avoid contaminations. ing to Chapter IV of his rule. 2.2.3.8. Physical-chemical and microbiological 2.1.1. Until receiving the results from the water control, performed at a public laboratory. tests above, all the batches or centers will be isolated, also prohibited for incubation. CHAPTER IX 2.2. Two evaluations should be used, considering the free centers or under surveillance, FORWARDING RESULTS and monitoring for Mycoplasma synoviae. 2.2.1. If tested positive for Mycoplasma 1. The laboratory test results must be is- synoviae on chickens, these centers may be sued on a standard form, and communicated ac- treated with antibiotics and retested after cording to the flowchart established: the antibiotic residue is eliminated from the 1.1. Negative result: send FAX or use oth- system. er means for the immediate communication to the requesting official veterinarian, and to 7. The MAPA standard Health Certificate will the poultry holdings. be issued by the DFA of the State of the poultry 1.2. Positive result: send FAX or other type holding after performing the minimum of three of immediate documentation to the DDA and to tests, to the establishment or centers free or un- the SSA/DFA, where the establishment is located, der surveillance and supervision for the agents who will notify it. treated in this rule. 8. This certificate will have its validity sub- CHAPTER X ject to performing the maintenance regarding the health issue of the aviary center or establishment. CERTIFICATION OF PREMISES 9. If the flock’s health situation is altered, the certificate will be revoked, with the option of rein- 1. When the result from the laboratory tests stating the certificate after the evaluation of the SSA/ referred in Chapter V of these rules test negative, DFA, and/or of the State Secretariat of Agriculture of the official service may proceed with the certifi- the state in which the poultry holding is located. cation of the aviary center and/or premises, as established in Chapter IV. CHAPTER XI 2. The samplings for the monitoring and certification will be accepted when performed by GENERAL TERMS the technician in charge before the MAPA and by the official service, being that the samplings are 1. The serological laboratory tests are al- exclusively performed by the federal inspector, or ways screening tests, with the possibility of oc- by the official veterinarian, or inspected and su- curring nonspecific crossed reactions. Therefore, pervised by one of them. only mycoplasmologic diagnostic is considered 3. Even after having complied with all previ- conclusive for the detection of the mycoplasmas ous requirements, in cases of death during the referred in these rules. first days of the batch, the poultry holding must 2. If the centers that tested positive for the forward material from thirty rejected or agoniz- agents of these rules are to be slaughtered, it ing birds to a official or accredited laboratory for should be performed at slaughterhouses with the isolation of mycoplasmas or PCR. If the diag- SIF, according to the rules of the DIPOA. nosis is confirmed, the poultry from the center 3. The monitoring of ratites will be per- 238 will be sanitary slaughtered, when dealing with formed according to the specific legislation of the pure breeds, great granparent and grandparent MAPA for the hygiene-health registry and control breeders, followed by an epidemiological inves- for this species. tigation by the official service. 4. Biosafety measures for incubation: 4. For parent breeders, the treatment will be 4.1. It is prohibited to hatch eggs from pure accepted and retested when positive for Myco- breeds, great grandparent, grandparent, and plasma synoviae. parent breeders that are under surveillance and 5. The poultry holding being certified as a official supervision in the same machine and in free aviary center will only be authorized to com- the same period, following the criterions of the mercialize poultry or hatching eggs from this superior provenance. center. The poultry holding that receives the cer- 4.2. It is prohibited to hatch eggs in the cen- tificate as a free establishment will be able to pro- ters that are under surveillance and monitored ceed with the commercialization of poultry and/ for Mycoplasma synoviae in the same machine, or hatching eggs from all the centers. and during the same period in which centers that 6. The poultry holding that is under surveillance are free of this agent are hatching. and supervision for Mycoplasma synoviae cannot 5. The SSA/DFA at which the poultry hold- commercialize its products internationally (hatching ing is located and the proper State Secretariat of eggs and chicks from the referred center). Agriculture are responsible, for this field and jurisdiction, for the definition of appropriate mea- tion of this normative will explained by the Direc- sures for solving health issues, as established in tor of the Animal Health and Inspection Depart- the Regulation of Animal Health and Inspection ment of the Animal and Plant Health and Inspec- and in the PNSA/SDA. tion Secretariat, of the Ministry of Agriculture, 6. The relevant questions as to the applica- Livestock and Food Supply.

SERVICE INSTRUCTION DDA No. 1 OF DECEMBER 14, 1999

Requirements for the entry of Pet Birds into the National Territory

The Ministry of Agriculture, Livestock, and issued in advance by MAPA. Food Supply-MAPA’s Animal Health Department- 2. The aforementioned International Zoo- DDA, by virtue of the powers vested in it under sanitary Certificate should be issued by the sani- Art. 2 of Administrative Ruling No. 144 of Decem- tary authority of the country of origin, attesting ber 23, 1997, hereby establishes the following: that in the thirty days prior to departure for Bra- 1. Pet birds, i.e., a maximum of four birds zil, the bird(s): that live with their owners and accompany them a) did not have any contact with wild fowls on this moving or travel occasion and are des- or domestic fowls raised in backyards or at indus- tined for residential addresses may enter the na- trial establishments; and tional territory, accompanied by an International b) has(have) not shown any clinical sign of Zoosanitary Certificate, without an authorization transmissible diseases.

HAMILTON RICARDO FARIAS

COMPLEMENTARY LEGISLATION

239

ADMINISTRATIVE RULING No. 126 OF NOVEMBER 3, 1995

Published in the Official Gazette of November 6, 1995 Section 1, Page 17694

Approves the “Norms on Accreditation and Monitoring of Diagnostic Laboratories for Avian Salmonellosis (S. enteritidis, S. gallinarum, S. pullorum, and S. typhimurium)”.

ADMINISTRATIVE RULING No. 208 OF DECEMBER 20, 1994

Published in the Official Gazette of December 26, 1994 Section 1, Page 20510

Approves the “Norms on Accreditation and Monitoring of Diagnostic Laboratories for Avian Mycoplasmoses.” ADMINISTRATIVE RULING No. 182 OF NOVEMBER 08, 1994

Published in the Official Gazette of November 11, 1994 Section 1, Page 17003

Approves the “Norms on Accreditation and Monitoring of Diagnostic Laboratories for Newcastle Disease.”

NORMATIVE INSTRUCTION No. 6 OF JUNE 2, 2003

Published in the Official Gazette of June 4, 2003 Section 1, Page 1

Provides for the authorization of importation of avian genetic material by the Ministry of Agriculture, Livestock, and Food Supply-MAPA, which shall comply with the sanitary requirements established under the Regulations of the Animal Health and Inspection Service, as well as taking into account the zootechnical conditions.

NATIONAL AQUATIC ANIMAL HEALTH PROGRAM

ADMINISTRATIVE RULING No. 573 OF JUNE 4, 2003

240 Published in the Official Gazette of June 5, 2003 Section 1, Page 11

Establishes the National Aquatic Animal Health Program.

THE PRO-TEM MINISTER OF AGRICULTURE Animal Health Program. AND FOOD SUPPLY, by virtue of the powers vest- Art. 2. To assign to the Agriculture and Live- ed in him under Art. 87, Sole Paragraph, II of the stock Health and Inspection Secretary the task of Constitution; having in view the provisions of the issuing the Program’s Internal Regulations and Animal Health Defense Regulations approved the requisite instructions for full implementation under Decree No. 24548 of July 3, 1934, and Pro- of the Program’s activities. ceeding No. 21000.007228/202-71, Art. 3. This Administrative Ruling shall enter RESOLVES: into force on the day of its publication. Art. 1. To establish the National Aquatic

JOSÉ AMAURI DIMARZIO NORMATIVE INSTRUCTION No. 18 OF MAY 13, 2008

Published in the Official Gazette of May 14, 2008 Section 1, Page 14

Establishes procedures for the importation of aquatic animals for ornamental purposes and destined for sale

THE MINISTRY OF AGRICULTURE, LIVESTOCK Art. 5. Aquatic animals for ornamental pur- AND FOOD SUPPLY’S AGRICULTURE AND LIVESTOCK poses imported for sale shall be subject to at least HEALTH AND INSPECTION SECRETARY, by virtue of seven days of quarantine at establishments ac- the powers vested in him under Arts. 9 and 42, An- credited for this purpose, as provided under the nex I of Decree No. 5351 of January 21, 2005, hav- Annex hereto. ing in view the provisions of Decree No. 5741 of Art. 6. Aquatic animals imported by reason March 30, 2006, Decree No. 24548 of July 3, 1934, of change of domicile must enter Brazil in the and Proceeding No. 21000.001351/2008-73, company of their owners, subject to prior autho- RESOLVES: rization and to international zoosanitary certifi- Art. 1. To establish procedures for the im- cation pursuant to Brazilian requirements. portation of aquatic animals for ornamental pur- Paragraph 1. The animals referred in this ar- poses, destined for sale. ticle’s heading shall be subjected to a ninety-day Art. 2. Aquatic animals for ornamental purpos- observation period under a veterinarian’s super- es and destined for sale are hereby exempted from vision at the destination domicile. compliance with the provisions under Art. 26 of SDA Paragraph 2. The owner shall act as deposi- Normative Instruction No. 53 of July 2, 2003. tary, and must submit a health certificate of the Sole paragraph. The provisions of this ar- animals to the Agricultural and Livestock Health ticle’s heading apply also to the importation of Service of the Federal Agriculture Superinten- aquatic animals for ornamental purposes, owing dence-SEDESA’s state unit at the expiration of the to change of domicile. period. Art. 3. The importation of crustaceans and Art. 7. Suspicion of disease in aquatic ani- live fishes of the Cyprinidae family shall be au- mals for ornamental purposes must be notified 241 thorized solely for reproduction purposes pursu- to the pertinent SEDESA state unit. ant to the provisions under art. 26 of SDA Norma- Sole Paragraph. Treatment of diseases while tive Instruction No. 53 of July 2, 2003. the animals are in quarantine or under observa- Art. 4. The importation of aquatic animals tion may be allowed, subject to express SEDESA for ornamental purposes shall be subject to risk authorization. analysis and compliance with the requirements Art. 8. This Normative Instruction shall enter under MAPA’s prior authorization. into force on the day of its publication.

INÁCIO AFONSO KROETZ ANNEX

REQUIREMENTS FOR ACCREDITATION OF QUARANTINE ESTABLISHMENTS FOR ORNAMENTAL AQUATIC ANIMALS

CHAPTER I nal and external areas. Art. 8. Facilities must have wash basins in MINIMUM INFRASTRUCTURE each dependency where animals are held.

Art. 1. Quarantine establishments must be CHAPTER II physically isolated from other facilities and have covered areas for housing quarantined animals STAFF AND PEOPLE TRANSIT CONTROL for protection from invader animals. Art. 2. Existing infrastructure should con- Art. 9. The quarantine establishment must sist of an internal environment, where animals operate under a Veterinarian’s Technical Respon- are to be housed, and an outer environment, sibility homologated by his Professional Council. where the administrative structure should be Art. 10. Staff must wash themselves upon located. entering or leaving the quarantine facilities. Support infrastructure for both internal and Art. 11. Staff must wear appropriate working outer environments should be built so as to min- clothes, which should be used exclusively at the imize the risks of spreading contamination (ad- quarantine facilities. ministration office, room for cleaning equipment Art. 12. Visits must be restricted, controlled, and utensils, laundry room, disposal of solid resi- and allowed solely with prior authorization by dues, etc.) and have locker rooms and toilets in the Technical Person in charge. both environments. Art. 13. Visitors must be entered into a log, Art. 3. Facilities and their dependencies and their last visit to an aquatic holding establish- should be visibly identified with signs indicating ment or other risk locations should be recorded. their purpose, so as to allow a logical work flow. Art. 14. A minimum period of 48 (forty- Art. 4. The internal finishing of facilities eight) hours after a visitor has been near aquatic 242 and reservoirs for housing animals must be animals or at risk locations is required for grant- of waterproof materials capable of enduring ing him/her authorization to visit the quarantine frequent cleaning and disinfection, as well as establishment. having efficient drainage for disposal of waste water and dirt. CHAPTER III Art. 5. Water supply must be from a safe source and subjected to treatment to ensure the CONTROL PROCEDURES destruction of pathogenic agents. Water reser- AND SANITARY RECORDS voirs should be supplied through a water distribution system. Art. 15. All documents pertaining to the Art. 6. Drained waste waters should be chan- movement of animals, people, and inputs as well neled to a treatment system approved by the Of- as any other quarantine establishment sanitary ficial Veterinary Service and by the environmen- records must be filed on the premises and remain tal agency and sanitation agencies. available to the Official Veterinary Service. Art. 7. The quarantine establishment must Art. 16. Protocols of procedures followed on have a fumigation or similar system for the dis- the quarantine establishment must be in print and infection of objects and utensils required by the manually organized, describing the management work, located at the division between the inter- of the animals, disinfections, as well as the physical, chemical, and biologic treatments dispensed, the ensuring the destruction of pathogenic agents. products and dosage or concentration employed, Art. 24. Inorganic materials should de disin- and the technical or scientific reference used. fected and appropriately discarded. Art. 17. The quarantine establishment shall prepare and adopt zoosanitary reports CHAPTER IV containing data on the animal stock, deaths, personnel, downtimes and disinfections, mon- QUARANTINE CONDITIONS itoring of waters to be utilized, currently used AND DISEASE OCCURRENCES or discarded, documentation on the movements of animals entering or leaving, control Art. 25. The quarantine period may be ex- of origin, and date of the entry and destina- tended according to the requirements set forth in tion of feed. These reports should be daily up- the prior import authorization, or to a change in dated under the supervision of the Technical the animals’ health condition. Person in charge. Art. 26. The admission of new lots of ani- Art. 18. The quarantine establishment must mals shall be allowed while quarantine is on, but have a log with typographically numbered pages, the quarantine period shall start anew. into which the Technical Person in charge shall Art. 27. At the expiration of the quarantine enter events of sanitary relevance. period, the facilities must be totally vacated and ob- Art. 19. The quarantine establishment shall serve a downtime of at least 24 (twenty-four hours) maintain a program for the control of vermin after the completion of cleaning and disinfection. and rodents and for preventing the presence of Art. 28. Expenditures on the forwarding of any animals other than those under quarantine. the official samples and of laboratory tests re- Art. 20. The lots of imported animals should quired for the monitoring of diseases shall be be kept separate in different tanks according to incumbent on the animals’ owner. origin and to species, so as to allow isolation, dis- Art. 29. In case of occurrence of a disease of infection, and treatment separately. mandatory notification or of high mortality with Art. 21. Each tank should keep current in- no definite cause, all quarantined animals shall formation including tank number and the ori- be preventatively destroyed and samples shall be gin, family, species, and number of individuals it collected for investigation. houses, as well as mortality record. Art. 30. Any quarantine establishment in non- 243 Art. 22. Each tank should have its own uten- compliance with the provisions hereunder shall be sils routinely used in handling the animals. subject to the following administrative sanctions: Art. 23. Organic residues or waste should be a) temporary disaccreditation; or incinerated or subjected to a treatment capable of b) definitive disaccreditation.

NORMATIVE INSTRUCTION No. 53 OF JULY 2, 2003

Published in the Official Gazette of July 4, 2003 Section 1, Page 2

Approves the Technical Regulations of the National Program on Aquatic Animal Health

THE MINISTRY OF AGRICULTURE, LIVESTOCK II, a of Decree No. 4629 of March 21, 2003 and AND FOOD SUPPLY’S AGRICULTURE AND LIVE- Art. 2 of Administrative Ruling No. 573 of June STOCK HEALTH AND INSPECTION SECRETARY, by 4, 2003; having in view the provisions under the virtue or the powers vested in him under Art. 15, Animal Health and Inspection’s Regulations approved under Decree no. 24548 of July 3, 1934; RESOLVES: Whereas there is a need to standardize pro- Art. 1. To approve the Technical Regula- phylactic actions, diagnostic, and sanitation in tions of the National Program on Aquatic Animal aquaculture establishments and to define the role Health. of public animal health defense agencies in jointly Art. 2. To delegate competence to the Ani- combating diseases that affect aquatic animals with mal Health and Inspection Department to issue breeders, private sector veterinarians, and labora- instructions complementary hereto. tories outside the Ministry of Agriculture, Livestock, Art. 3. This Normative Instruction shall enter and Food Supply’s laboratory network; and in view into force on the day of its publication. of Proceeding No. 21000.007229/2002-15,

MAÇAO TADANO

ANNEX

TECHNICAL REGULATIONS OF THE NATIONAL PROGRAM ON AQUATIC ANIMAL HEALTH - PNSAA

These technical regulations shall apply to so as to ensure sanitary control and aquatic ani- sanitary control at aquaculture establishments mals’ health, thereby reducing the risk of introduc- engaged in activities connected with aquatic tion and dissemination of pathogenic agents. animal farming and marketing and related ac- SANITARY CERTIFICATE: document issued by tivities, as well as preventing the introduction the pertinent official agency indicating the sani- of exotic diseases and controlling or eradicating tary status of the breeding establishment in re- existing diseases in the country. spect of the monitoring of diseases of mandatory notification and of those subject to certification, CHAPTER 1 pursuant to current legislation. CYST: a latent, dry egg (Artemia spp). Definitions OFFICIAL VETERINARY CONTROL: routinely performed service by the competent veterinary 244 For the purposes of these regulations, the authority at aquaculture establishments and following definitions shall apply: zones to ensure the animals’ health and compli- ALEVIN: the first life stage of a fish after ance with PNSAA requirements. hatching, morphologically similar to the adult of CRUSTACEAN: aquatic animals belonging to the same species. the Arthropoda phylum, characterized by a chitin AQUATIC ANIMAL: fishes, mollusks, crusta- exoskeleton, articulated appendages, and includ- ceans, and other animals appropriate for aqua- ing shrimp, crab, freshwater crab, crayfish, man- culture at any development stage. grove crab, isopod, ostracod, and amphipod. AQUACULTURE: farming of aquatic ani- ORNAMENTAL SPECIES: aquatic animal at mals, including fishes, mollusks, crustaceans, any development stage for the purposes of dis- and other animals that have in water their first play or ornament. development stage. EXOTIC SPECIES: aquatic animals originating BIOSECURITY: measures pertaining to sanitary and occurring naturally outside the limits of Bra- issues, cleaning, and disinfection; control of the zilian waters, irrespective of whether they have al- transit of people, animals, and vehicles; garbage ready been artificially introduced in these waters. and effluents disposal; control of the security of the AQUACULTURE ESTABLISHMENT: establish- physical facilities of quarantine establishment and ment where aquatic animals are breed or kept of zones of farming of aquatic animal populations for reproduction or selling purposes. OUTBREAK: emergence of a disease at an AQUATIC ANIMAL PRODUCTS: products des- aquaculture establishment. tined for breeding (eggs, embryos, cysts, gam- GAMETE: genetic material (semen/ovule) of etes, larvae, alevins, etc.), human or animal aquatic animals, separately kept or transported consumption, or for pharmaceutical, biologi- before fecundation. cal, or industrial purposes. ANIMAL MOVEMENT PERMIT-GTA: manda- BIOLOGIC PRODUCT: biological reagent used tory document for the movement of aquatic ani- for the diagnostic of certain diseases, serum for mals, required for any movement or purpose. prevention and treatment of some diseases, vac- QUARANTINE UNIT QUALIFICATION: Official cines for disease prevention, genetic material of Veterinary Service’s evaluation of an establish- infectious agents, and endocrine tissue from fish ment destined for quarantining aquatic animals or used in fishes. in view of the risk of introduction and dissemina- TECHNICAL PERSON IN CHARGE: veterinarian tion of pathogenic agents. responsible for sanitary control at aquaculture ACCREDITED LABORATORY: laboratory of a establishments. federal, state, municipal institution, or private SEED: any young aquatic animal form, in- qualified and accredited by MAPA for the identifi- cluding egg, embryo egg, alevin, nauplius, larva, cation of pathogenic agents. and post-larva. OFFICIAL LABORATORY: laboratory belong- OFFICIAL VETERINARY SERVICE: animal ing to the Ministry of Agriculture, Livestock, and health and inspection service at the federal, state, Food Supply’s laboratory network. and municipal level. LARVA: stage of aquatic animal’s life that fol- QUARANTINE UNIT: wholly separated facility lows the embryonic stage, susceptible of present- or ensemble of facilities under biosecurity condi- ing various development phases. tions, destined for receiving live aquatic animals LOT: group of aquatic animals at an aqua- at any development stage after transportation or culture establishment belonging to the same importation. species, originating from the same hatching, and that have shared the same water supply. CHAPTER II HYDROGRAPHIC MICROBASIN: physiographic area circumscribed by watersheds and drained COMPETENCES by a water course or a system of interconnected 245 water courses converging, directly or indirectly, Art. 1. It shall be incumbent on the Animal into a bed or pool. Health and Inspection Department, Agriculture MOLLUSC: aquatic animal of the Mollusca and Livestock Defense Office-SDA, Ministry of phylum, of the Metazoa subgenus, character- Agriculture, Livestock, and Food Supply-MAPA, ized by a soft body without segmentation, most to normalize, coordinate, and execute the Pro- of whose species are protected by a calcareous gram activities, while field actions shall be in- shell, and including oysters, mussels, and scal- cumbent on the Animal Health Sector/Section/ lops (pectines). Service, Federal Agriculture Office-DFA, and on MONITORING OF POPULATIONS: sanitary the State Departments of Agriculture or their follow-up combined with laboratory analyses, animal health and inspection agencies, under including serologic tests, experiments with bio- agreements celebrated with MAPA. logical and nonbiological materials, and epidemiologic analysis of aquatic animals’ health con- CHAPTER III ditions, and standardizing results. QUARANTINE PERIOD: Period between the PRELIMINARY DISPOSITIONS reception of live aquatic animals at the quarantine establishment and their release by the Of- Art. 2. The Animal Health and Inspection ficial Veterinary Service. Department shall coordinate the disease prevention measures hereunder so as to bar the of ornamental aquatic animals, live bait, and live introduction of exotic diseases and to control aquatic animals for consumption. or eradicate existing diseases on the national territory. Art. 3. The entry into the national territory CHAPTER V of aquatic animals affected or under suspicion of being affected by directly or indirectly trans- REGISTER OF AQUACULTURE missible diseases, even if apparently healthy, is ESTABLISHMENTS hereby prohibited, as is the entry of bearers of external or internal parasites whose dissemina- Art. 7. The aquaculture establishment regis- tion might pose a threat to the national aquatic ter shall be incumbent on the State Departments animal population. of Agriculture or their animal health and inspec- Art. 4. The entry of aquatic animal prod- tion agencies. ucts, subproducts, remains, viscera, living feed, or any other material assumed to be a vehicle of agents of contagious diseases is also hereun- CHAPTER VI der prohibited. Art. 5. The entry of aquatic animals from coun- NOTIFICATION OF SUSPICION tries where the diseases referred to hereunder ex- OR OCCURRENCE OF DISEASE ist in an enzootic state shall be allowed solely with prior DDA authorization, which shall set the condi- Art. 8. Diseases of mandatory notification tions under which importation will be allowed. are exotic diseases and those that pose a threat to the country’s economic, public health, and environment. CHAPTER IV Art. 9. The veterinarian, owner, or any other individual that has knowledge or suspicion CLASSIFICATION OF of the occurrence of diseases of mandatory AQUACULTURE ESTABLISHMENTS notification should promptly notify the Official Veterinary Service. Art. 6. For the purposes hereunder, estab- 246 lishments engaged in aquaculture activities are classified as follows: CHAPTER VII I – REPRODUCTION ESTABLISHMENT: establishment destined for reproduction or ma- INSPECTION AND SANITARY CONTROL nipulation of genetic material (gametes/eggs/ OF AQUACULTURE ESTABLISHMENTS nauplius/seed). II – BREEDING ESTABLISHMENT: culture es- Art. 10. All aquaculture establishments are tablishment or zone destined for the breeding of subject to inspection by the Official Veterinary aquatic animals (alevin/larva/post larva). Service. III – FATTENING ESTABLISHMENT: culture es- Art. 11. In case of noncompliance with the re- tablishment or zone engaged in raising aquatic quirements hereunder, as identified by the official animals from early in the life cycle up to the mar- service, the following sanctions may be adopted: keting stage. I – Suspension of the importation, exporta- IV – RECREATION ESTABLISHMENT: estab- tion, and marketing authorization and of the is- lishment where aquatic animals are destined for suance of GTAs; pleasure fishing (fish and pay). II – Establishment’s interdiction; or VI – SELLING ESTABLISHMENT: establish- III - Application of other sanitary measures ment engaged exclusively in the sale and resale determined by DDA. CHAPTER VIII by fax, e-mail, or another means of communication to the official veterinarian requesting the IMPORTATION AND EXPORTATION tests and to the establishment in question; and OF ANIMALS II – Positive results: To be immediately sent by fax, e-mail, or another means of communica- Art. 12. Any aquaculture establishment en- tion to the DDA and to the SSA/DFA under whose gaged in international trade must comply with jurisdiction the establishment is located. DDA norms. Art. 21. Once the identification of the patho- Art. 13. For the purposes of importation genic agent referred to under Art. 8 hereunder of aquatic animal products, the interested party is confirmed, all aquatic animals in a shipment should secure prior importation authorization must be immediately sacrificed and destroyed, from the DFA in the state where the aquaculture and every necessary prophylactic measure shall establishment is located. be taken, and the owner shall not be entitled to Art. 14. In the case of importation of wild any indemnification of any kind. exotic or ornamental species, prior IBAMA autho- Art. 22. The sacrifice of animals referred to rization shall be required. in the preceding article shall be done as provided Art. 15. Upon arrival at the national territo- under Decree No. 24548 of July 3, 1934. ry, imported aquatic animals and aquatic animal Art. 23. The costs of official sample collection products shall be transferred in their still sealed for laboratory tests and of samples’ remittance to shipment containers to the quarantine unit pre- reference or MAPA-accredited laboratories for this viously qualified by DDA, for sanitary monitoring purpose shall be fully born by the interested party. and confirmation of the absence of pathogenic Art. 24. If no positive result has been reagents of the diseases specified by DDA, accord- corded by the expiration of the quarantine pe- ing to the origin of said animals and products. riod, the state SSA/DFA shall inform the interested Art. 16. Sanitary monitoring shall be carried party about the lot’s release. out at the quarantine unit in accordance with the Art. 25. The quarantine period for the dif- quarantined species, and controlled by the Offi- ferent species of aquatic animals at any develop- cial Veterinary Service. ment stage shall last long enough for the analysis Art. 17. The collection of samples from and conclusions by official laboratory results. aquatic animals and aquatic animal products Art. 26. Release into bodies of water shall be 247 shall be done by the Animal Health Service/DFA permitted solely of an imported lot’s first-generation upon arrival at the quarantine unit, and shall offspring (F1). The original lot shall remain under iso- be sent for laboratory tests, accompanied by the lation and sanitary surveillance at the reproduction appropriate form, pursuant to the provisions of establishment for the entire reproduction period. specific legislation. Art. 27. The downtime between quarantines Art. 18. Any material officially collected by must be for a minimum period sufficient for the the veterinarian must be sealed and accompa- cleaning and disinfection of all facilities. nied by the requisite standard DDA form. Art. 28. DDA shall authorize, register, and Art. 19. If a disease causing agent is iden- revoke any authorization for the operation and tified during the quarantine period, the DDA functioning of all quarantine units as well as shall notify the interested party in writing of maintaining current information on the disease the test results within a maximum of 72 (sev- causing agents identified in quarantine units, the enty-two) hours and proceed to the destruction procedures adopted in case of diseases of man- of the positive lots. datory notification, and test results. Art. 20. Laboratory test results must be is- Art. 29. All materials and equipment used sued on the DDA’s appropriate standard form and at the quarantine unit must be kept clean and transmitted according to the following flowchart: disinfected with specific products duly regis- I – Negative results: To be immediately sent tered with DDA. Art. 30. The admission of people, vehicles, V – Sanitary sacrifice: depending on the dis- equipment, and materials to the quarantine ease, all the animals on the farm establishment unit’s internal areas shall be permitted only in or zone shall be sacrificed, and their conditional compliance with strict biosecurity measures. use shall be defined by the Official Veterinary Art. 31. Access to the quarantine facility must Service; be through a single entry and exit point provided VI – Therapeutic treatment: in viable cases, with washing and disinfection equipment. diseased animals shall be treated; Art. 32. In the case of fairs and expositions, VII – Disinfection: if disinfection is needed, the following conditions must be observed: a harvest shall be undertaken, followed by total I – Compliance with DDA’s pertinent norms emptying and appropriate disinfection for the and specific legislation; time necessary to exterminate the disease caus- II – Control of diseases of mandatory notifi- ing agent, and all requisite measures shall be cation; and taken to prevent it from invading natural water III – Should diseases of mandatory notifica- bodies; tion occur in the region, the Official Veterinary VIII – Outbreak monitoring: the farm estab- Service shall adopt restrictive measures for the lishment or zone as well as the other establish- event’s realization. ments located in the perifocal area and basin should be regularly visited for the purposes of CHAPTER IX monitoring the disease’s status and the execution of the recommended measures as well as ACTIVITIES IN THE OCCURRENCE the adoption of other procedures aimed at the OF A OUTBREAK disease’s control or total eradication; and IX – Outbreak closing: once the inexistence Art. 33. Whenever there is notification of a of pathogenic agents is confirmed, as well as suspected outbreak of a disease of mandatory the successful emptying and disinfection of the notification, the following procedures shall be farm establishments or zones, the outbreak adopted: shall be declared closed and the interdiction I – Visit to the outbreak: initial visit, collection shall be lifted. of material and its shipment to the laboratory, accompanied by the duly filled-out requisite forms; CHAPTER X 248 II – Epidemiologic tracing: based on information that leads the veterinarian to determine MOVEMENT OF ANIMALS the outbreak’s origin, and define its extent, evolution, spread, and consequences; Art. 34. The movement of aquatic animals III – Interdiction of the outbreak and perifo- shall be authorized only if accompanied by the cal areas: according to the diseases’ seriousness, Animal movement permit-GTA. the culture establishments or zones shall be in- Art. 35. The issuance of a GTA for any purpose terdicted, together with the neighboring proper- shall be subject to compliance with the require- ties and microbasins; ments under DDA norms and specific legislation. IV – Outbreak notification: the outbreak shall be notified to the local Official Veterinary Art. 36. Vehicles or containers used in the Service, which in turn shall notify the state vet- transportation of aquatic animals should be de- erinary service through the appropriate form, signed, built, and conditioned so as to bear the for epidemiologic analysis and the adoption of combined weight of the animals and the water, a pertinent decision consistent with the disease’s to ensure their safety in transit. seriousness. Notification must be immediate in Art. 37. The vehicles carrying aquatic ani- case of suspicion of the diseases referred to un- mals should be washed and disinfected pursuant der Art. 8 hereunder; to DDA norms. Art. 38. Containers for transporting aquatic has occurred or from a farm zone where none of animals should be watertight. such diseases has been detected in the previous Art. 39. Aquatic animals should be packed 90 (ninety) days. in a transport container appropriate for allowing easy inspection during transportation. CHAPTER X Art. 40. Residual and rinsing water should not be drained in a way susceptible of reaching GENERAL DISPOSITIONS natural waters. Art. 41. Waste water from transport contain- Art. 43. To advise DDA in reference to specif- ers may be discarded on lands that do not drain ic issues hereunder, a Consultative Committee on into waters peopled by aquatic animals, or treat- the National Program on Aquatic Animal Health- ed according to DDA standard procedures. CC/PNSAA shall be set up as well as State Animal Art. 42. GTAs shall be issued solely in case Health Committees-COESAAs). of animals and products from aquaculture estab- Art. 44. Omissive cases and doubts pertain- lishments in which, during the previous cycle, no ing to these regulations’ application shall be re- outbreak of diseases of mandatory notification solved by DDA.

NORMATIVE INSTRUCTION No. 39 OF NOVEMBER 4, 1999

Published in the Official Gazette of November 8, 1999 Section 1, Page 43

Temporarily suspends the admission into the national territory of all crustacean species, whether salt or fresh water, at any development stage of their biologic cycle, whether fresh, frozen, or cooked, whole in their carapaces or parts thereof, from any origin.

THE MINISTRY OF AGRICULTURE, LIVESTOCK Whereas the admission of live or processed AND FOOD SUPPLY’S AGRICULTURE AND LIVE- crustaceans and their subproducts for cultiva- STOCK HEALTH AND INSPECTION SECRETARY, by tion, marketing, or research into the Brazilian 249 virtue of the powers vested in him under Art. territory poses a high dissemination risk of the 83, IV of the Department’s Internal Regulations causing agents of these diseases, which may en- approved under Ministerial Administrative Rul- tail losses to aquaculture and the natural crus- ing No. 574 of December 8, 1998, having in tacean populations; view the provisions under the Animal Health Whereas to date there has been no occur- and Inspection Service’s Regulations approved rence of these diseases in crustacean farms in under Decree no. 24548 of July 3, 1934; Brazil, Whereas the diseases known as White RESOLVES: Shrimp Spot Virus-WSSV and Yellow Head Vi- Art. 1. Temporarily to suspend the ad- rus-YHV included on List b of the World Or- mission into the national territory of all crus- ganization for Animal Health-OIE have been tacean species, whether salt or fresh water, at detected in shrimp farming facilities in vari- any development stage of their biologic cycle, ous countries; whether fresh, frozen, or cooked, whole in their Whereas the countries where these viruses’ carapaces or parts thereof, from any origin. presence has been confirmed have adopted Sole Paragraph. The suspension hereun- measures restricting the importation of crus- der is extensive to Artemia salina and all ma- taceans and products and subproducts thereof; rine polyquet species. Art. 2. To subject import authorizations here- countries of origin and their production areas. under to prior risk analysis by the Animal and Art. 3. Import authorizations already is- Plant Health and Inspection Secretariat’s Animal sued and not yet used are hereby cancelled. Health and Inspection Department, which shall Art. 4. This Normative Instruction shall en- take into account the zoosanitary situation of the ter into force on the day of its publication.

LUÍS CARLOS DE OLIVEIRA

NATIONAL CAPRINE AND OVINE HEALTH PROGRAM

NORMATIVE INSTRUCTION No. 20 OF AUGUST 15, 2005

Published in the Official Gazette of September 12, 2005, Section 1, Page 20.

Approves the Procedures for the Operationalization of the Sanitary Register of Goat and Sheep Raising Establishments.

THE ANIMAL AND PLANT HEALTH AND IN- Art. 1. To approve the PROCEDURES FOR SPECTION SECRETARY, MINISTRY OF AGRICUL- THE OPERATIONALIZATION OF THE SANITARY TURE, LIVESTOCK AND FOOD SUPPLY, by virtue of REGISTER OF GOAT AND SHEEP RAISING ESTAB- the powers vested in him under Art. 42, Annex LISHMENTS, pursuant to Annex I hereto, as well 250 I of Decree No. 5351 of January 21, 2005; hav- as the form model shown in Annex II, for infor- ing in view the Animal Health and Inspection mation on the private veterinarian that will fol- Regulations approved under Decree No. 24548 low up such establishments in connection with of July 3, 1934; SDA Normative Instruction No. PNSCO certification programs, and the form 87 of December 10, 2004; and Proceeding No. model shown in Annex III, for minimum infor- 21000.008578/2004-16; mation for the inclusion of such establishments Whereas there is a need to define aspects rein the sanitary register. lated to the National Caprine and Ovine Health Art. 2. This Normative Instruction shall en- Program-PNSCO, RESOLVES: ter into force on the day of its publication.

GABRIEL ALVES MACIEL ANNEX I

PROCEDURES FOR THE OPERATIONALIZATION OF THE SANITARY REGISTER OF GOAT AND SHEEP RAIS- ING ESTABLISHMENTS

Art. 1. This Normative Instruction applies to XI – SFA: Federal Agriculture, Livestock, and the procedures for the operationalization of the Food Supply Superintendence. National Caprine and Ovine Health Program

CHAPTER II CHAPTER I ACTION STRATEGIES DEFINITIONS Art. 3. PNSCO action strategies are based on Art. 2. For the purposes hereunder, the fol- mandatory animal health and inspection pro- lowing definitions shall apply: cedures, complemented by voluntary adhesion I – ESTABLISHMENT CERTIFICATION: confir- measures, including the following: mation of an establishment as disease free af- I – Sanitary register of establishments; ter compliance with Animal Health Department II – Control of the movement of animals; and requirements; III – Voluntary certification of establish- II – DISEASE OF MANDATORY NOTIFICATION: ments. any disease classified by the Animal Health De- partment as being of mandatory notification to CHAPTER III the Official Service; III – ESTABLISHMENT: property on which OFFICIAL SERVICE COMPETENCE goats and sheep are kept under common management conditions; Art. 4. It is incumbent on the Disease Com- IV – ACCREDITED LABORATORY: laboratory bating General Coordination Office, Animal Health approved for performing diagnostic tests by us- Department, to plan, control, and evaluate the ex- ing techniques recognized and approved by the ecution of plans under the National Caprine and 251 Agriculture and Livestock Defense’s Laboratory Ovine Health Program aimed at the surveillance, Support Coordinating Office; control, prophylaxis, and eradication of goat and V – MAPA: Ministry of Agriculture, Livestock sheep diseases, under official control. and Food Supply; Sole Paragraph. PNSCO addresses the tech- VI – OFFICIAL VETERINARIAN: Federal and niques available in Brazil and recommended by State Official Service Veterinarian; OIE. Diagnostic technologies and vaccines may VII – PRIVATE VETERINARIAN: Private sector be adopted and recommended after being evalu- veterinarian who may be hired by an establish- ated by the Animal Health Department. ment owner to perform tasks for the establish- Art. 5. It is incumbent on the Agriculture ment in connection with certification and certifi- and Livestock Health and Inspection’s Laboratory cates, without costs for the State; Support Coordinating Office to standardize diag- VIII – OIE: World Organization for Animal nostic techniques used as a tool in the detection Health; of diseases encompassed by PNSCO, to do the IX – PNSCO: National Caprine and Ovine yearly verification of records and provide infor- Health Program; mation to PNSCO upon request. X – OFFICIAL SERVICE: Federal and State Ani- … mal Health and Inspection Services; and Art. 7. It is incumbent on the SFA in each state to issue and renew certificates to disease- maintain the status as being free of the diseases free establishments, pursuant PNSCO norms. that are the target of the official programs, pursuant to the requirements under the pertinent CHAPTER IV normative acts. Sole Paragraph. In case of replacement of ESTABLISHMENTS REGISTER the Independent Veterinarian responsible for monitoring a certified establishment or an estab- Art. 8. For the purposes hereunder, establishment in the process of obtaining certification, lishments engaged in raising goats and sheep the establishment’s owner should immediately must apply for registration with the State Official forward the data on the new Independent Veteri- Services by filling out the standard form for basic narian to the SFA of the state in which the estab- information (Annex III). lishment is registered, and the new professional Paragraph 1. Another form may be used, pro- must comply with the provisions under Art. 13 vided they contain the basic information required hereunder within a maximum of fifteen days of for filling out the form shown in Annex III. the communication. Paragraph 2. Information provided for reg- Art. 12. The Veterinarian responsible for an istration must be updated within a period not to establishment in the process of certification or exceed one year. already certified must attend meetings and en- Art. 9. As of the date to be set by the Ani- counters promoted in the respective region by mal Health Department, GTAs for the interstate the Animal Health Department/MAPA or Official movement of goats and sheep not destined for Service to address issues pertaining to PNSCO. slaughter shall be issued only if the animals to be Art. 13. To undertake the monitoring of an transported originate in establishments that are establishment in the process of certification or current with their sanitary register. already certified, an Independent Veterinarian Art. 10. The Animal Health Department may must submit to the SFA in the state where the prohibit the movement of goats and sheep from monitored establishment is located the following a registered establishment in case of confirmed documents: sanitary risk of transmission of infecto-conta- I – A filled-out information form (Annex II); gious diseases to other establishments that keep II- Statement of being current with the Re- goat and sheep herds. gional Veterinary Medicine Council-CRMV of the 252 state where he works; and CHAPTER V III – An Affidavit pursuant to the model established by the Animal Health Department for INDEPENDENT VETERINARIAN every Certification Program that includes monitoring. Art. 11. All establishments that participate Sole Paragraph. In case of noncompliance in the Official Certification Programs under PNS- with the legislation, the Independent Veterinary CO must be monitored by an Independent Veteri- responsible for an establishment in the process narian, who shall be responsible for the activities of certification or already certified shall be sub- necessary for the establishments to achieve and jected to the applicable sanctions. ANNEX II

MODEL OF FORM TO BE FILLED OUT WITH INFORMATION ON AN INDEPENDENT VETERINARIAN RE- SPONSIBLE FOR MONITORING AN ESTABLISHMENT IN THE PROCESS OF CERTIFICATION OR ALREADY CERTIFIED UNDER PNSCO

3 cm x 4cm Photo

Name: Parents’ names: ID: Taxpayer ID: CRMV Graduating Institution: Year of graduation: Post-graduation (1): Year of completion: Post-graduation (2): Year of completion: Current job / Main activity Home address: Business address: Telephone: Fax: Cell phone: E-mail:

Attachments: 1. Statement from the CRMV in the state with which the interested party is registered and current. 2. Signed affidavit pursuant the model established by the Animal Health Department. 253 ANNEX III

MODEL FORM FOR MINIMUM INFORMATION FOR THE SANITARY REGISTER OF GOATS AND SHEEP ESTABLISHMENTS

Name: C.G.C.: Name of the establishment’s owner: C.P.F.: Telefone: e-mail: Full address: Postal Code: Municipality: State: Latitude/Longitude: Total area: Facilities total area: Establishment’s Category: Reproduction Production Management type: Intensive Extensive Mixed Purpose: Meat Leather Wool Milk Mixed Handles animal products or subproducts for commercial purposes Yes No Origin of animals: Importation Genetic bank Own Another property Mixed Specify origin: Trade in animals or animal multiplication material: Local Intrastate Interstate International Number of animals: 254 Goats Males Females <6 months > 6 months < 3 years >3 years Sheeps Males Females <6 months > 6 months < 3 years >3 years Animal identification system: Tattoo Earring Electronic Other* (*Specify) Breed (Check the code in the list below):

Goat breeds code: 1.5. Canindé 1.1. Anglo Nubian 1.6. Graúna 1.2. Azul 1.7. Gurguéia 1.3. Bhuj 1.8. Marota 1.4. Boer 1.9. Moxotó 1.10. Murciana 2.13. Highland 1.11. Alpine 2.14. Ideal 1.12. Repartida 2.15. Ile de France 1.13. Saanen 2.16. Lacaune 1.14. Savanna 2.17. Karakul 1.15. Toggenburg 2.18. Merino 1.16. Other (include on the form) 2.19. Merlin 1.17. SRD (not well-defined breed) 2.20. Morada Nova 2.21. Oxsfordshire Sheep breeds code: 2.22. Polypay 2.1. Bergamasca 2.23 Ryeland 2.2. Blackface 2.24. Romeldale 2.3. Border Leicester 2.25. Romney Marsh 2.4. Cariri 2.26. Santa Inês 2.5. Corriedale 2.27. Shrospire 2.6. Crioula 2.28. Somalis 2.7. Deslanado do Nordeste 2.29. Suffolk 2.8. Dorper 2.30. Targhee 2.9. Dorset 2.31. Texel 2.10. East Friesian 2.32. Wilstermach 2.11. Hampshire Down 2.33. Other (specify on the form) 2.12. Hardwick 2.34. SRD (without well-defined breed)

NORMATIVE INSTRUCTION No. 87 OF DECEMBER 10, 2004

Published in the Official Gazette of December 20, 2004 Section 1, Page 21 255

Approves the National Caprine and Ovine Health Program Technical Regulations

THE MINISTRY OF AGRICULTURE, LIVESTOCK RESOLVES: AND FOOD SUPPLY’S AGRICULTURE AND LIVESTOCK Art. 1. To approve the NATIONAL CAPRINE HEALTH AND INSPECTION SECRETARY, by virtue of AND OVINE HEALTH PROGRAM TECHNICAL REGU- the powers vested in him under Art. 15, II of Annex LATIONS hereto annexed. I to Decree No. 4629, of March 21, 2003, having in Art. 2. This Normative Instruction shall enter view the Animal Health and Inspection Regulations in force on the date of its publication. approved under Decree No. 24548 of July 3, 1934, Art. 3. Normative Instruction No. 53 of July and Proceeding No. 21000.011263/2003-75, 12, 2004 is hereby revoked.

MAÇAO TADANO ANNEX

NATIONAL CAPRINE AND OVINE HEALTH PROGRAM TECHNICAL REGULATIONS-PNSCO

Art. 1. These National Caprine and Ovine XII – INDEPENDENT VETERINARIAN: a veterinar- Health Program Technical Regulations-PNSCO ap- ian from the private sector who monitors registered ply to activities geared to the production and mar- establishments without entailing costs to the State; keting of goats and sheep and their genetic material XIII – DISEASE NOTIFICATION: official com- nationwide in connection with regards zoosanitary munication of the occurrence of cases of a given surveillance and health and inspection. disease to the competent authority; XIV – PARASITE: organism or micro-organism CHAPTER I which exists at a host’s expense; XV – OWNER: natural person or legal entity, DEFINITIONS public or private, which owns animals or real es- tate for any purpose; Art. 2. For the purposes hereunder, the fol- XVI – QUARANTINE: restraining of people, lowing definitions shall apply: plants, and animals for a given period during I – DDA: Animal Health and Inspection De- which measures determined by the sanitary au- partment; thorities are applied to prevent the introduction II – DESTRUCTION – Procedure for the elimi- and spread of disease, its hosts or vectors; nation of animals without their utilization for XVII – HERD: a group of animals kept under consumption, done on the raising establishment common management conditions at the same itself or on a location approved by the Official raising establishment; Service pursuant to DDA approved criteria; XVIII – SANITARY SACRIFICE: slaughter of ani- III – DFA: Federal Agricultural Office; mals for controlling diseases, at slaughterhouses IV – DISEASE: alteration in an individual under federal, state, or municipal inspection; [animal]’s balanced condition vis-à-vis itself or XIX – SDA: Animal and Plant Health and In- the environment; spection Secretariat; V – DISEASE OF MANDATORY NOTIFICATION: XX – OFFICIAL SERVICE: animal health and 256 disease classified as such by DDA, which should inspection service at the federal and state level. be compulsorily notified to the Official Service af- XXI – EPIDEMIOLOGIC SURVEILLANCE: ongoing, ter detection of clinical suspicion of the disease; systematic investigation of health data pertaining to VI – ESTABLISHMENT: location where goats a given population (sample collection, analysis, and and sheep are raised under common manage- interpretation) to verify a disease’s occurrence, an ac- ment conditions; tivity that is essential to the planning, implementa- VII – GTA: Animal movement permit; tion, and evaluation of sanitary measures aimed at VIII – INTERDICTION: prohibition, at the Official controlling or eradicating the disease; and Service’s discretion, of the admission to or exit from XXII – SANITARY SURVEILLANCE: a set of mea- any establishment of animals, their products and sures aimed at eliminating, reducing, or preventing subproducts as well as any other material likely to be risks to public health, as well as controlling and ensur- the means of transmission or spread of a disease; ing compliance with sanitary norms and standards. IX – MAPA: Ministry of Agriculture, Livestock, and Food Supply; CHAPTER II X – GENETIC MATERIAL: semen, embryo, ovo- cyte, cell nucleus, or any other material capable COMPETENCE of transmitting genes to the offspring; XI – OFFICIAL VETERINARIAN: a veterinarian Art. 3. It shall be incumbent on DDA/SDA/ belonging to the federal or state Official Service; MAPA to establish norms and to coordinate and supervise activities under PNSCO. It shall be in- maintaining the certification status, pursuant to cumbent on State Agriculture Departments or the requirements of Normative Acts. their Animal Health and Inspection agencies to Sole Paragraph. The federal and state Offi- execute activities by delegation. cial Services may at any time audit the activity of the veterinarians responsible for executing the CHAPTER III planned activities at establishments in the process of certification or already certified. PRELIMINARY DISPOSITIONS Art. 9. The veterinarian responsible for an establishment in the process of certification or Art. 4. The admission into the National Territo- already certified must attend meetings and en- ry of goats and sheep that are bearers of directly or counters promoted in his region by DDA/MAPA or indirectly transmissible diseases and of internal or Official Services on issues pertaining to PNSCO. external parasites whose dissemination may pose a threat to national herds is hereby prohibited. CHAPTER VII Art. 5. The admission into the National Ter- ritory of animal products and any other materials DISEASE NOTIFICATION AND that pose a risk of introducing diseases affecting SURVEILLANCE goats and sheep is hereby equally forbidden. Art. 10. Under current legislation, public or CHAPTER IV independent veterinarians and owners or their deputies, must immediately inform the Official OBJECTIVES Service of any suspicion of goat and sheep disease of mandatory notification. Art. 6. To undertake the epidemiologic and Paragraph 1. In the specific case of foot-and- sanitary surveillance of goat and sheep diseases mouth disease, the measures called for under in Brazil through measures defined by DDA and current legislation must be taken, implemented by the Official Services and inde- Paragraph 2. The Official Service shall adopt pendent veterinarians. the veterinary care and surveillance measures determined by DDA for each specific disease. CHAPTER V 257 CHAPTER VIII RAISING ESTABLISHMENTS REGISTER INSPECTION AND SANITARY Art. 7. All establishments must be regis- CONTROL OF ESTABLISHMENTS tered by the state Official Services pursuant to a DDA standard form. Art. 11. All establishments shall be subject Sole Paragraph. The register must be annu- to inspection by the Official Service. ally updated. Art. 12. In case of noncompliance with the requirements under the PNSCO legislation, the CHAPTER VI following measures may be adopted, at the Of- ficial Service’s discretion: INDEPENDENT VETERINARIANS I – Suspension of the importation or exportation authorization and of the issuance of GTAs; Art. 8. All establishments in the process of II – Establishment’s interdiction; certification or already certified must be moni- III – Destruction; tored by an independent veterinarian, who shall IV – Sanitary sacrifice; and be responsible for keeping records and for un- V –Adoption of other sanitary measures es- dertaking the activities required for securing and tablished by DDA. CHAPTER IX by a GTA in accordance with current normative requirements. CERTIFICATION REQUIREMENTS Art. 17. Goats and sheep must be transported in appropriate vehicles that have been cleaned Art. 13. DDA shall implement the strategy and disinfected prior to shipment. for certification of establishments that meet the specific sanitary requirements under current legislation, as well as complying with the norms per- CHAPTER XII taining to sanitation, surveillance, and control of the diseases specified under PNSCO. EXPOSITIONS, FAIRS, AUCTIONS AND OTHER CHAPTER X CONGLOMERATIONS

PRODUCTION, MARKETING AND Art. 18. The participation of goats and sheep IMPORTATION OF GENETIC MATERIAL in expositions, fairs, actions, and other conglomerations shall be subject to compliance with cur- Art. 14. For the purposes of production and rent norms and legislation. marketing of genetic material, establishments must comply with DDA sanitary norms. Art. 15. For the purposes of importation of CHAPTER XIII goats, sheep, and their genetic material, the interested party must apply for prior authorization GENERAL DISPOSITIONS from the DFA in the state where his establishment is located. Art. 19. To advise DDA on the specific Paragraph 1. Upon arrival in the National issues hereunder, a National Caprine and Territory, imported goats and sheep must be kept Ovine Health Program National Consultative in a quarantine unit previously qualified by DDA Technical Committee shall be established as until their release by the Official Service. well as State Caprine and Ovine Health Com- Paragraph 2. In case of occurrence of dis- mittees. eases during the quarantine period, the Official Sole Paragraph. In each state, the Federal 258 Service shall adopt the sanitary measures perti- Agriculture Office Director shall set up a State nent to each situation. Committee on Caprine and Sheep Health, consisting of representatives from DFA’s Animal CHAPTER XI Health and Inspection, the State Health and Inspection Services, research and teaching in- MOVEMENT OF GOATS AND SHEEP stitutions, and the productive sector. Art. 20. Omissive cases and doubts about the Art. 16. The movement of goats and application of these Regulations and the comple- sheep shall be allowed only if accompanied mentary legislation shall be resolved by DDA. COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING SDA No. 47 OF JULY 20, 2004

Establishes the National Consultative Committee on the National Caprine and Ovine Health Program’s

NATIONAL BEEKEEPING HEALTH PROGRAM

NORMATIVE INSTRUCTION No. 16 OF MAY 8, 2008

Published in the Official Gazette of May 9, 2008 Section 1, Page 27

Establishes the National Beekeeping Health Program-PNSAp under the Ministry of Agricul- ture, Livestock, and Food Supply.

THE MINISTRY OF AGRICULTURE, LIVESTOCK Paragraph 2. PNSAp shall be coordinated by AND FOOD SUPPLY’S AGRICULTURE AND LIVE- a representative from the Animal Health Depart- STOCK HEALTH AND INSPECTION SECRETARY, by ment-DSA. virtue of the powers vested in him under Arts. 9 Paragraph 3. So as to prevent, control, and and 42 of Annex I to Decree No. 5351 of Janu- eradicate diseases and pests susceptible of caus- 259 ary 21, 2005, having in view the provisions of ing damage to the beekeeping productive chain, Decree No. 24548 of July 3, 1934; Decree No. PNSAp shall carry out the following activities: 5741 of March 30, 2006; and Proceeding No. I – Sanitary education; 21000.002627/2008-31, II – Epidemiologic studies; RESOLVES: III – Movement control; Art. 1. To establish the National Beekeeping IV – Registration, inspection, and sanitary Health Program-PNSAp under the Ministry of Ag- certification; and riculture, Livestock, and Food Supply. V – Prompt intervention in case of suspicion Paragraph 1. PNSAp aims at strengthen- or occurrence of disease or pest of mandatory ing the beekeeping productive chain through notification. animal health and inspection and surveillance Art. 2. This Normative Instruction shall enter actions. into force on the day of its publication.

INÁCIO AFONSO KROETZ COMPLEMENTARY LEGISLATION

ADMINISTRATIVE RULING No. 9 OF FEBRUARY 18, 2003

Published in the Official Gazette of February 20, 2003 Section 1, Page 10

Establishes the Consultative Scientific Committee on Beekeeping Health-CCCSA to provide technical and scientific input to the Animal Health and Inspection Department-DSA on the drafting of norms and procedures related to the health of the Brazilian bee population and to the importation of bees and bee products.

ADMINISTRATIVE RULING No. 248 OF DECEMBER 30, 1998

Published in the Official Gazette of January 5, 1999 Section 1, Page 13

Establishes the analytical methodology for the detection of Bacillus larvae, an agent of bee larvae disease, known as American foulbrood, in honey.

NORMATIVE INSTRUCTION No. 18 OF APRIL 8, 2008

Published in the Official Gazette of April 9, 2008 Section 1, Page 8

Incorporates into the Brazilian legislation the “Zoosanitary requirements for the importation of queen bees and bee products destined for the States Parties,” approved 260 under Resolution GMC-MERCOSUR NO. 23/07.

NATIONAL EQUID HEALTH PROGRAM

NORMATIVE INSTRUCTION No. 17 OF MAY 8, 2008

Published in the Official Gazette of May 9, 2008 Section 1, Page 27

Establishes the National Equid Health Program-PNSE under the Ministry of Agriculture, Livestock, and Food Supply.

THE MINISTRY OF AGRICULTURE, LIVESTOCK virtue of the powers vested in him under Arts. 9 AND FOOD SUPPLY’S AGRICULTURE AND LIVE- and 42 of Annex I to Decree No. 5351 of January STOCK HEALTH AND INSPECTION SECRETARY, by 21, 2005, having in view Decree No. 24548 of July 3, 1934; Decree No. 5741 of March 30, 2006; and and eradicate diseases susceptible of causing Proceeding No. 21000.002656/2008-96, damage to the equine agriculture and livestock RESOLVES: sector, PNSE shall carry out the following actions: Art. 1. To establish the National Equid Health I – Sanitary education; Program-PNSE, under the Ministry of Agriculture, II – Epidemiologic studies; Livestock, and Food Supply. III – Animal movement control; Paragraph 1. PNSE aims at strengthening the IV – Registration, inspection, and sanitary equine agricultural and livestock sector by means certification; and of animal health and inspection and surveillance. V – Prompt intervention in case of suspi- Paragraph 2. PNSE shall be coordinated by cion or occurrence of diseases of mandatory a representative from the Animal Health and In- notification. spection Department. Art. 2. This Normative Instruction shall enter Paragraph 3. To prevent, diagnose, control, into force on the day of its publication.

INÁCIO AFONSO KROETZ

NORMATIVE INSTRUCTION No. 45 OF JUNE 15, 2004

Published in the Official Gazette of July 7, 2004 Section 1, Page 7

Approves Norms for the Prevention and Control of Equine Infectious Anaemia-EIA.

THE MINISTRY OF AGRICULTURE, LIVESTOCK Art. 2. To delegate to the Director of the AND FOOD SUPPLY’S AGRICULTURE AND LIVE- Animal Health and Inspection Department the STOCK HEALTH AND INSPECTION SECRETARY, by competence for issuing administrative rulings virtue of the powers vested in him under Art. 15, and other requisite acts to enforce the norms II of Annex I to Decree No. 4629 of March 21, 2003, hereunder. having in view Decree No. 24548 of July 3, 1934, Art. 3. This Normative Instruction shall enter and Proceeding No. 21000.001089/2002-71, into force on the day of its publication. 261 RESOLVES: Art. 4. Normative Instruction No. 16 of Feb- Art. 1. To approve Norms for the Prevention ruary 18, 2004 is hereby revoked. and Control of Equine Infectious Anaemia-EIA.

MAÇAO TADANO

ANNEX

NORMS FOR THE PREVENTION AND CONTROL OF EQUINE INFECTIOUS ANAEMIA-EIA.

Art. 1. For the purposes hereunder, the fol- II- Equine Infectious Anaemia-EIA: infectious lowing definitions shall apply: disease caused by a lentivirus and which may I – Sanitary slaughtering: slaughtering of assume the following clinical conditions: acute, EIA-infected equines at slaughterhouses under chronic, and no apparent symptoms; Federal Inspection, subject to prior authorization III – Carrier animal: any equine tested EIA by the Animal Health Department of the state of positive by an official laboratory; the animals’ origin;. IV – High-risk area: geographical region where EIA is known to be endemic and where CHAPTER II environmental conditions help maintain and disseminate the disease; GENERAL PROCEDURES V – Perifocal area: area surrounding the outbreak, to be circumscribed by the Official Art. 2. Field actions pertaining to EIA pre- Veterinary Service; vention and control are incumbent on the Offi- VI – Confirmation test: laboratory EIA diag- cial Veterinary Service in each state, under DDA nostic testing of original sample that has been coordination. labeled, sealed, and kept at -20ºC for diagnostic Art. 3. EIA prevention and control measures confirmation; shall be adopted in the states in accordance with VII – Equine: any animal of the Equidae their specific epidemiologic conditions. family, including horses, donkeys, and mules; Art. 4. The Director of the Federal Agricul- VIII – Outbreak: property on which there is tural Office in each state shall appoint a State one or more than one EIA carrier equine; Commission on the Prevention and Control of IX – Isolation: keeping of an EIA car- Equine Infectious Anaemia-EIA (CECAIE), which rier equine in a circumscribed area as deter- shall have the following attributions: mined by the Official Veterinary Service so as I – To propose sanitary measures for EIA pre- to prevent the disease’s transmission to other vention and control in the state; and equines; II – To evaluate the work done in the state. X – Accredited laboratory: a laboratory Art. 5. CECAIE shall consist of ten mem- that has been accredited by the Animal Health bers –five office holders and five deputies, as and Inspection Department-DDA for EIA diag- follows: nostic testing; I – One veterinarian from DFA’s Animal XI – Official laboratory: a DDA laboratory; Health and Inspection Service-SSA, who shall act XII – Numbered seal: inviolable numbered as coordinator; seal; II – One veterinarian from the state Animal XIII – Property: public or private rural or Health and Inspection Service; urban establishment holding equines for any III – One veterinarian designated by equine purpose; raisers; XIV – Owner: natural person or legal en- IV – One veterinarian designated by the State 262 tity that owns or keeps one or more than one Veterinary Medicine Society; and equine for any purpose; V – One veterinarian who is a specialist or ex- XV – Quarantine: isolation of a clinically perienced in EIA, designated by Veterinary Medi- healthy equine recently arrived at a controlled cine educational or research institution. property from a noncontrolled property in a specific location at least 200 (two hundred) me- CHAPTER III ters from any other property, or protected with an insect-proof screen until said animal tests PERSON RESPONSIBLE FOR negative at two consecutive EIA tests at a 30-60 REQUESTING EIA DIAGNOSTIC TESTS day interval; XVI – Retesting: EIA laboratory diagnostic Art. 6. To be able to request an EIA diagnos- testing by an official laboratory of sample from tic test, a veterinarian must be registered with animals tested positive; and the Regional Veterinary Medicine Council in the XVII – Official Veterinary Service: the Ani- respective state. mal Health Service under the Federal Agricul- Art. 7. It shall be incumbent on the vet- tural Office-DFA in each state, and the Animal erinarian: Health and Inspection under the State Secre- I – To collect test material; and tariat of Agriculture. II – To submit a filled-out official request form (Annex I) to a DDA-accredited diagnostic ter receipt of the positive results of the first test laboratory. until the final determination, when the pertinent Sole Paragraph. For an animal’s identifica- measures shall be adopted. tion, an accurate, full written, graphic description Art. 15. Accredited laboratories must submit of it, including all marks, shall be required. a report on its activities to the Federal Agricultur- Art. 8. The requesting veterinarian shall be al Office’s Animal Health Service of the respective liable for the veracity and accuracy of the infor- state by the fifth working day of the subsequent mation submitted by him. month (Annex III). Art. 16. Producers of antigen for EIA diag- CHAPTER IV nostics must submit to the state SSAs a monthly report on the product’s sale to their respective EIA LABORATORY states (Annex IV). DIAGNOSTIC TESTS CHAPTER V Art. 9. For EIA diagnostic tests, the serologic agar-gel immunodiffusion (AGID) test shall be OUTBREAK used and shall be performed with an antigen registered with and approved by DDA; or any other Art. 17. Once a outbreak is detected, the fol- officially accepted serologic test. lowing measures shall be adopted: Art. 10. The laboratorial diagnostic test re- I – Interdiction of the property after identi- sults shall be released on the same request form. fication of the carrier equine, entry of the occur- Paragraph 1. Positive results must be im- rence into the records, notification of the owner mediately forwarded to the DFA’s SSA of the state of the prohibition of the exit of equines from the where the positive tested animal is located. property and of the movement of items suscep- Paragraph 2. Negative results must be for- tible of being carriers of the EIA virus; warded to the requesting veterinarian or to the II – Epidemiologic investigation of all ani- animal’s owner. mals that tested EIA positive, including their Art. 11. For a serologic survey aimed at prop- movement record; erty control, the form titled “Request and results III - Permanent branding of EIA carrier ani- of Equine Infectious Anaemia test for the purpose mals with a hot iron on the left shoulder, with 263 of a serologic survey” (Annex II) shall be used. This an “A” within a circle 8 cm (eight centimeters) form is not valid for the movement of animals. in diameter, followed by the state abbreviation, Art. 12. EIA laboratory tests’ negative results pursuant to the model in Annex V; shall be valid for 180 (one hundred eighty) days IV – Sacrifice or isolation of carrier equines; for controlled properties, and for 60 (sixty) days for V – Laboratory EIA testing of all equines on other cases, as of the date of sample collection. the property; Art. 13. The animal’s owner may request re- VI – Lifting of the interdiction of the out- testing, by applying to the DFA’s SSA of the respec- break property after two EIA negative tests on tive state within a maximum of eight days after all equines on the property, at an interval of 30 receiving notification of the results. The -confir (thirty) to 60 (sixty) days; and matory test shall be performed by the same labo- VII – Orientation to the owners of properties ratory that did the first testing. in the perifocal area, by the Official Veterinary Art. 14. Retesting shall be performed by an Service, to submit their animals to laboratory official laboratory on sample collected by the of- testing for EIA. ficial service for investigation purposes. Sole Paragraph. Branding of equines is in- Sole Paragraph. Should an owner request cumbent on the Official Veterinary Service, and confirmatory test or retesting in case of positive shall not be required if the animals are immedi- results, the animal must remain in isolation af- ately sacrificed or sent for sanitary slaughtering. If the transportation of the animals to the slaugh- a high-risk area, as indicated by the CECAIE of terhouse requires a stop for rest or feeding, the the respective state. animals must be branded and the rest stop must Art. 25. The equine permanently branded as be previously approved by the respective state’s EIA carrier found in another property or in transit Animal Health Service. shall be summarily sacrificed in the presence of two witnesses, save if confirmedly destined for CHAPTER VI slaughter. The property on which such an animal is found shall be considered as an outbreak. SACRIFICE OR ISOLATION CHAPTER VII Art. 18. The sacrifice or isolation of EIA carrier equines shall be determined pursuant to DDA CONTROLLED PROPERTY norms after analysis of the measures proposed by CECAIE. Art. 26. A property shall be considered con- Art. 19. The sacrifice of a carrier animal shall trolled if it has no animal that has tested positive be done by the Official Veterinary Service within in two consecutive EIA diagnostic tests performed a maximum of 30 (thirty) days as of the diag- at a 30 (thirty) to 60 (sixty) day interval. nostic test result, preferentially on the property Art. 27. To maintain its EIA controlled status, where the animal is located. a property must submit its entire equine herd to Sole Paragraph. If the sacrifice of the carrier testing once every six months, with negative re- animal cannot be done on the property, the sani- sults, tary slaughter may be done at a slaughterhouse Sole Paragraph. Testing at a shorter interval with Federal Inspection Service, and the animal may be determined at the discretion of the state’s should be transported in an appropriate vehicle Official Veterinary Service. with a numbered seal applied at the origin. Art. 28. A property declared as controlled Art. 20. The sacrifice of a carrier animal must for EIA by the respective state’s SSA shall be grant- be fast and painless and done under the respon- ed a certificate at the request of the interested sibility of the Official Veterinary Service. party, who should use the form shown in Annex Art. 21. The sanitary sacrifice shall be en- VII hereto for the purpose. This certificate shall be tered into the records (Annex VI). The entry shall renewed every 12 (twelve) months, after testing 264 be signed by the official veterinarian, the ani- of the entire equine herd mal’s owner or his legal proxy, and at least one Art. 29. The sanitary monitoring of a con- witness. trolled property shall be incumbent on an inde- Art. 22. The sacrificed animal’s owner shall pendent veterinarian under the supervision of not be entitled to indemnification. the respective state’s Official Veterinary Service. Art. 23. Should the owner or his legal proxy Art. 30. It shall be incumbent on the inde- refuse to accept the notification of the property’s pendent veterinarian referred to in the preced- interdiction or the carrier animal’s sacrifice, such ing: refusal shall be entered into the records in the I – To keep current the clinical and laborato- presence of two witnesses, and the police shall rial control of the equines on the property; be called in to ensure the enforcement of the II – To report immediately any EIA suspected sanitary measure, while the infringer shall be case to the Official Veterinary Service and to adopt subjected to the penalties under the law. the sanitary measures envisaged hereunder; Art. 24. Should the measure adopted be the III – To watch over the property’s hygiene carrier animal’s isolation, the animal must be and sanitary conditions; branded as provided under Art. 17, III hereunder. IV – To submit equines from noncontrolled Sole Paragraph. Isolation shall be al- properties to quarantine before incorporating lowed only in the case of carrier animals in them into the controlled herd; and V – To see that the controlled property sub- collection date, in case such an equine crosses or mits a monthly report on its activities to the re- remains in an uncontrolled property. spective state’s SSA by the fifth working day of the Art. 35. An equine under six months of age subsequent month (Annex VIII). is exempted from EIA testing, if accompanied Art. 31. A controlled property shall lose its by its mother, provided the latter has tested status in case of noncompliance with any of the negative for EIA. conditions set forth under this chapter. Sole Paragraph. An equine under six months age descending from a positive tested animal, CHAPTER VIII shall be isolated for a minimum of 60 (sixty) days, and at the expiration of this period must be sub- MOVEMENT CONTROL mitted to two consecutive laboratory diagnostic tests for EIA with negative results at an interval of Art.32. The interstate movement of equines 30 (thirty) to 60 (sixty) days before being incorpo- shall be permitted only if accompanied by an of- rated into the negative herd. ficial movement permit and proof of negative Art. 36. The entry of equines into the results of the EIA laboratory diagnostic test. National Territory shall be subject to proof of Sole Paragraph. Equines destined for slaugh- negative EIA test results, in addition to other ter are exempted from the proof of having been sanitary requirements. tested for EIA. The transporting vehicle must be sealed at the origin with a numbered seal en- CHAPTER IX tered into the movement permit; the seal shall be broken at the final destination by the Federal GENERAL DISPOSITIONS Inspection Service. Art. 33. The participation of equines in ag- Art. 37. All biological products from equine ricultural and livestock events shall be allowed origin for prophylactic or therapeutic use must only if tested negative for EIA. have been prepared from animals from con- Sole Paragraph. The events should fall trolled properties. within the period of validity of the negative test Art. 38. For the purposes of definitive ge- certificate. nealogic records, equines must be tested nega- Art. 34. The validity of an EIA negative test tive for EIA. 265 certificate of an equine from a controlled prop- Art. 39. Omissive cases hereunder shall be erty shall be shortened from 180 (one hundred resolved by the Animal Health and Inspection eighty) days to 60 (sixty) days as of the sample Department. ANNEX I

REQUEST AND RESULT OF DIAGNOSTIC TEST FOR EQUINE INFECTIOUS ANAEMIA

Laboratory Accreditation Administrative Ruling Test nº.: Address: Telephone: City / State: E-mail: Animal’s owner: Full address: Telephone: Requesting Veterinarian: Full address: Telephone:

Name of animal Brand Record nº. CLASSIFICATION Species: Breed: JC ES H F MU OTHER Sex: Age: Property where located: Nº. of equines on the property: Municipality/State:

Upper line of vision Right side Left side 266

Left Right Left Right

Neck/ lower Muzzle Front legs / Rear view view Hind legs / Rear view

Animal’s description REQUESTER: LABORATORY: The sample collection from and Antigen – Brand or Name description on this animal are under my Lot nº. responsibility. Test result date ______, ______,____ Result Municipality and date of sample collection ______Validity date Requesting Signature and seal of Professional in charge Veterinarian’s signature and seal

JC: Jockey Club; ES: Equestrian Society; H: Haras; F: Farm; MU: Military Unit

267 ANNEX II

MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY ANIMAL AND PLANT HEALTH AND INSPECTION SECRETARIAT ANIMAL HEALTH AND INSPECTION DEPARTMENT

REQUEST AND RESULT OF DIAGNOSTIC TEST FOR EQUINE INFECTIOUS ANAEMIA (FOR THE PURPOSE OF SEROLOGIC SURVEY)

No. LABORATORY: TELEPHONE: ADDRESS: REQUESTING VETERINARIAN TELEPHONE: CRMV ADDRESS: OWNER OF ANIMAL(S): TELEPHONE: FAX: ADDRESS:

ANIMALS’ IDENTIFICATION No. in Name or No. Test No. Species Breed Gender Age in Pelage Result order (H, D, M) months

268 NOT VALID FOR MOVEMENT OF ANIMALS

MANUFACTURING LABORATORY ANTIGEN USED: LOT No.: VALIDITY:

REQUESTING VETERINARIAN:

Place and date Seal and signature

PROFESSIONAL IN CHARGE OF LABORATORY

Place and date Seal and signature

1st copy – owner (attached to GTA) 2nd copy - SSA-DFA 3rd copy- Laboratory ANNEX III

MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD Monthly LABORATORY: SUPPLY ANIMAL AND PLANT HEALTH AND INSPECTION Report SECRETARIAT ANIMAL HEALTH AND INSPECTION on Equine DEPARTMENT Infectious Anaemia

MONTH / YEAR: Page:

State Municipality TOTAL

Properties Positive Negative Tested

269

TOTAL

No. OF PROPERTIES WITH CARRIER ANIMALS, Signature and seal ACCORDING TO THEIR CLASSIFICATION JC ES H F UM OTHER

JC: Jockey Club ES: Equestrian Society H: Haras F: Farm MU: Military Unit ANNEX IV

Monthly report on the marketing of “EIA diagnosis Kit” Month / Year ______/ ______

State Accredited Municipality Veterinarian Lot Validity Kits Qty. Laboratory in Charge

Signature / Seal

ANNEX V

270 ANNEX VI

SANITARY SACRIFICE AFFIDAVIT

On ______(month / day / year, at ______(hour) on the (Property’s name) ______located at ______the equines indicated below were sacrificed pursuant to DAS Normative Instruction No. ______, of (month / day / year ______, in accordance with the attached test(s)

Animal’s name or number Test No. Date Laboratory

Total

Veterinarian in charge

Name/Seal Signature

Animal’s owner or legal proxy

Name/ID Signature

Witness 271 Name/ID Signature

Witness

Name/ID Signature ADMINISTRATIVE RULING No. 24 OF APRIL 5, 2004

Published in the Official Gazette of April 12, 2004 Section 1, Page 7

Approves Norms on Glanders Control and Eradication.

THE MINISTRY OF AGRICULTURE, LIVESTOCK and Proceeding NO. 21000.001675/2003-5, AND FOOD SUPPLY’S ANIMAL AND PLANT HEALTH RESOLVES: AND INSPECTION SECRETARY, by virtue of the Art. 1. To approve Norms on Glanders Con- powers vested in him under Art. 83, IV of the trol and Eradication. Department’s Internal Regulations approved un- Art. 2. The Animal Health and Inspection der Ministerial Administrative Ruling No. 574 of Department-DDA shall issue norms complemen- December 8, 1998; having in view the provisions tary to this Normative Instruction as necessary. of the Animal Health and Inspection Regulations Art. 3. This Normative Instruction shall enter approved under Decree no. 24548 of July 3, 1934, into force on the day of its publication.

MAÇAO TADANO

ANNEX

NORMS ON GLANDERS CONTROL AND ERADICATION

CHAPTER I to MAPA’s diagnostic laboratories network; 272 Registered Veterinarian: a veterinarian regis- DEFINITIONS tered with the DFA Animal Health Service in the state and qualified for collecting and submitting Art. 1. For the purposes hereunder, the fol- material for the performance of laboratory glan- lowing definitions shall apply: ders diagnostic testing; Equid: Any animal of the Equidae family, in- Official Veterinarian: a veterinarian of the cluding horses, donkeys, and mules; state or federal animal health and inspection Outbreak: Any establishment where the ex- service; istence of one or more than one animal infected Property subject to sanitation procedures: with the glanders agent (Burkholderia mallei) is establishment subjected to sanitation procedures detected and confirmed by the Official Veterinary after its confirmation as a outbreak; Service; Interdicted property: establishment where Fomites: materials supposedly or provenly the Official Veterinary Service has suspected the contaminated with the glanders agent; occurrence of glanders, and where animal health Accredited Laboratory: a laboratory officially and inspection measures have been applied by the qualified by the Ministry of Agriculture, Livestock, Official Veterinary Service, including the temporary and Food Supply-MAPA for performing glanders prohibition of the entry and exit of equids; diagnostic testing; Monitored property: establishment whose Official Laboratory: a laboratory belonging equid herd is periodically subjected to clinical exams and laboratory tests pursuant to DDA norms, ly communicated to the SSA/DFA of the state where with a view to the property’s certification; the reactive animal is located. Positive results may Property: any establishment, public or pri- be sent directly to the Animal Health and Inspec- vate, rural or urban, where equids are kept for tion Service of the State Secretariat of Agriculture, any purpose; at the discretion of the state SSA. Owner: any natural person or legal entity Paragraph 2. Negative results should be sent that owns or holds one or more than one equid to the requesting veterinarian or to the animal’s for any purpose; owner. Mallein Test: allergic hypersensitivity test 6. Samples for glanders testing from any performed by inoculation of Mallein Purified state should be accompanied by the request/re- Protein Derivative (PPD) on the lower eyelid of sult form approved under Normative Instruction equids suspected of being affected by glanders; (Annex I). Complement Fixation Test (CF): serologic test Art. 3. CF reactive animals may be subjected based on the detection of glanders specific anti- to complementary diagnostic testing, namely, bodies in equids; the mallein test, in the following cases: Sanitary Regime: set of animal health and 1. CF reactive animals that show no clinical inspection measures applied by the Official Vet- symptoms of the disease. erinary Service, consisting of the Animal Health 2. CF non-reactive animals that show clinical and Inspection Department-DDA/SDA/MAPA; the symptoms of the disease. Animal Health Service of the Federal Agricultural 3. Other cases, as the DDA may deem neces- Office in the states; and the Animal Health and sary. Inspection Service of the Agricultural Secretariat, Art. 4. The mallein complementary testing or other specific state agencies. shall not be done in the following cases: 1. CF reactive animals that show clinical CHAPTER II symptoms of the disease; in this case, the CF test shall be considered conclusive. DIAGNOSTIC 2. Animals from a relapsing property, which shall be immediately subjected to the Sanitary Art. 2. For the purposes of glanders serologic Regime; in this case, the CF test shall be consid- diagnostic, the Complement Fixation (CF) test or ered conclusive. 273 another test previously approved by the Animal Art. 5. The mallein test shall be performed Health and Inspection Department-DDA shall be through intradermal application of a Mallein PPP adopted. at a dosage of 0.1 ml on the lower eyelid of one 1. The CF test may be performed solely by an of the animal’s eyes; the reading should be done official or accredited laboratory. 48 hours after the application. 2. A negative CF test result shall be valid for Sole Paragraph. The mallein test must be 180 (one hundred days) in the case of animals performed by an official service veterinarian. from monitored properties, and for 60 (sixty) days 1. Animals showing oedematous swelling of in other cases. the eyelid with or without purulence after mal- 3. The collection of material for glanders lein application shall be considered positive. testing for any purpose must be done by an of- 2. Animals that do not show reaction to mal- ficial or registered veterinarian. lein must be retested 45 (forty-five) to 60 (sixty) 4. Forwarding material for glanders testing days after the first mallein application. must be done only by an official or registered vet- 3. The diagnostic of animals remaining non- erinarian. reactive after the second mallein application shall 5. The result of the laboratory diagnostic test be considered conclusive, and the official health shall be issued on the respective application form. and inspection service shall issue the pertinent cer- Paragraph 1. Positive results must be prompt- tificate (Annex II), which shall be valid for 120 (one hundred twenty) days, during which period the an- CHAPTER V imals may not be submitted to the CF test again. Art. 6. At DDA’s discretion, other measures EQUIDS’ PARTICIPATION may be adopted in accordance with the assess- IN HORSE EVENTS ment of epidemiological conditions and with the advance of diagnostic means for the control and Art. 11. The participation of equids in eques- eradication of glanders. trian events in states where glanders cases have been confirmed shall be restricted to animals meeting the following requirements: CHAPTER III 1. Valid proof of negative glanders test results, pursuant to Annex I or Annex II. CERTIFICATION OF PROPERTIES 2. Absence of glanders clinical signs. MONITORED FOR GLANDERS

Art. 7. The certification of properties being CHAPTER VI monitored for glanders shall be voluntary and the requisite conditions shall be subject to spe- CONTROL OF INTERSTATE cific regulations to be issued by the DDA. MOVEMENT OF EQUIDS

Art. 12. The interstate movement of equids CHAPTER IV from a state where the occurrence of the glanders agent has been confirmed must meet the ERADICATION OF A GLANDERS OUTBREAK following sanitary requirements: 1. Valid proof of negative glanders test re- Art. 8. A property found to have one or more sults, according to Annex I or to Annex II. than one animal conclusively tested for glanders 2. Absence of glanders clinical signs. shall be considered an outbreak of the disease Art. 13. Equids from glanders-free states enter- and immediately interdicted and subjected to ing states where the glanders agent has been detect- the Sanitation Regime measures. ed; and returning to their state of origin or to another Art. 9. Positive animals shall be immedi- glanders-free state must be in compliance with the 274 ately sacrificed and no indemnification shall requirements listed in the preceding Art. 12. be granted (pursuant to Decree No. 24538 of July 3, 1934). After the sacrifice, the carcasses CHAPTER VII shall be incinerated or buried on the same site, and the premises and fomites shall be dis- CONTROL OF THE INTRASTATE infected by the Official Veterinary Service. All MOVEMENT OF EQUIDS the remaining equids shall be subjected to the glanders diagnostic tests referred to in Chapter Art. 14. The state animal health and inspec- II hereunder. tion services shall issue norms on the control of 1. The sacrifice of positive equids must be the intrastate movement of equids. done by an Official Veterinary Service professional in the presence of two reliable witnesses. Art. 10. The property’s interdiction shall be CHAPTER VIII lifted by the Official Veterinary Service after the sacrifice of positive animals only after -the per GENERAL DISPOSITIONS formance of two successive CF tests of the entire herd at 45- and 90- day intervals, with negative Art. 15. Notification of a suspected out- diagnostic test results. break may be done by the owner, surveillance services, or third parties. sanitary surveillance or of interest to the ani- Art. 16. The costs of glanders diagnostic mal health service. tests shall be defrayed by the animal’s owner, Art. 17. Omissive cases shall be resolved except for tests performed for the purposes of by DDA.

ANNEX I

GLANDERS DIAGNOSTIC CF TEXT REQUEST AND RESULT FORM

Laboratory Accreditation Normative Ruling Test Nº. (State) SERIALS Nº. Animal’s Owner Address Telephone Requesting Veterinarian Address Telephone Name Registration Nº. / Mark CLASSIFICATION Species: Breed: JC ES CR H BF MU Gender: Age: Property where the animal is located Number of equids on the property Municipality/State

Pelage:

Upper line 275 of vision Right side Left side

Left Right Left Right

Neck/ lower Muzzle Front legs / Rear view view Hind legs / Rear view Animal’s description:

OFFICIAL REQUESTER: LABORATORY:

The animal was examined by me today: Test date: Result: Place and date: Validity:

Professional in charge’s signature Veterinarian’s hand and seal and seal Professional in charge’s signature and seal

JC: Jockey Club; ES: Equestrian Society; CR: Cancha reta; ; H: Haras; F: Breeding Farm; MU: Military Unit

276 ANNEX II

MALLEIN TEST REQUEST AND RESULT FORM

Animal’s owner Address Telephone Requesting veterinarian Address Telephone Name Registration/ No./Mark CLASSIFICATION Species: Breed: JC ES CR H BF MU Gender: Age: Property where the animal is located No. of equids on the property Municipality/State CF test No.: Laboratory where the CF test was performed:

Pelage

Upper line of vision Right side Left side

277

Left Right Left Right

Neck/ lower Muzzle Front legs / Rear view view Hind legs / Rear view

MALLEIN APPLICATION DATE: READING DATE TEST RESULTS INTERPRETATION: ( ) POSITIVE ( ) NEGATIVE ( ) VALID NAME OF PROFESSIONAL IN CHARGE OF THE TEST: SIGNATURE AND SEAL

JC: Jockey Club; ES: Equestrian Society; CR: Cancha reta; ; H: Haras; BF: Breeding Farm; MU: Military Unit NORMATIVE INSTRUCTION No. 12 OF JANUARY 29, 2004

Published in the Official Gazette of February 5, 2004 Section 1, Page 1

Defines Quality Criteria for Accreditation and Monitoring of Laboratories for Glan- ders Serologic Diagnostic based on the Complement Fixation Technique.

THE MINISTRY OF AGRICULTURE, LIVESTOCK ders Serologic Diagnostic based on the Comple- AND FOOD SUPPLY’S AGRICULTURE AND LIVE- ment Fixation Technique, the pertinent proce- STOCK HEALTH AND INSPECTION SECRETARY, by dures, and annexes. virtue of the powers vested in him under Art. Art. 2. Accreditation referred to in the pre- 15, II of Annex I to Decree No. 4629 of March ceding article shall be granted Public Laborato- 21, 2003 and under Art. 4 of Ministerial Nor- ries for official serologic surveys, movement of mative Instruction No. 516 of December 9, animals, and surveillance in case of outbreaks, 1997, having in view SDA Normative Instruction and Private Laboratories in regard solely to the No. 51 of June 27, 2003 and Proceeding No. movement of animals. In addition, the Animal 21000.000039/2004-39, Health and Inspection Department-DDA may es- RESOLVES: tablish other criteria as needed. Art. 1. To define Quality Criteria for Accredi- Art. 3. This Normative Instruction shall enter tation and Monitoring of Laboratories for Glan- into force on the day of its publication.

RUI EDUARDO SALDANHA VARGAS

ANNEX

QUALITY CRITERIA FOR ACCREDITATION AND MONITORING OF LABORATORIES FOR GLANDERS SERO- 278 LOGIC DIAGNOSTIC

1. OBJECTIVE 3.2. Reference inputs: To define quality criteria for the accredita- -Complement tion of laboratories by the Animal Laboratory Co- - Hemolysin ordinating Office-CLA, Animal Health and Inspec- - sheep red blood cells at 2 percent tion Department-DDA. - Glanders antigen 2. APPLICATION - High positive control serum The criteria hereunder shall apply to both - Low positive control serum public and private laboratories solely in respect - Negative control serum of DDA needs as regards their number and geo- - Reagent and cyanmethemoglobin stan- graphical location. dard kit 3. MATERIAL Provision of these inputs shall be incumbent 3.1. Antigen on each accredited laboratory. 3.1.1. Only controlled antigens and serums 3.3. Sample to be analyzed: equine blood registered with the Ministry of Agriculture, Live- serum. stock, and Food Supply-MAPA or imported under 4. SAMPLE HANDLING MAPA authorization may be used, within their 4.1. Samples must be properly identified and validity period. kept under refrigeration; 4.2. Samples must be accompanied by appli- request and/or to the interested party. cation and results report forms, pursuant to the 7.2. Every accredited laboratory must submit model in Annex III hereto; a monthly report on its activities by the fifth busi- 4.2.1. Public accredited laboratories shall re- ness day of the subsequent month to the DFA’s ceive samples equally accompanied by the forms SSA where the laboratory is located, as well as to indicated by DDA for cases of the disease’s epide- CLA, pursuant to Annex IV hereto, whether tests miologic surveillance; have been performed or not. 4.3. Samples must be daily entered into an 7.3. Only the technical professional or his appropriate log, pursuant to the model provided deputy may sign the test result form and the by CLA in Annex IV; monthly report. 4.4. Samples must be divided into two por- 8. LABORATORY tions of equal volume sufficient for the perfor- 8.1. A laboratory must have the facilities, mance of tests and confirmation tests; equipment, glassware, utensils, and solutions 4.5. The test confirmation label (Annex V) appropriate for the performance of the Comple- must be filled out and sealed together with the ment Fixation test. confirmation test samples. The seal shall be 8.2. The facilities should allow an operating made of plastic, numbered, and inviolable. flow appropriate for the activities to be carried 5. CONSERVATION AND STORING out by the laboratory. 5.1 The sample to be analyzed must be kept 9. FACILITIES under refrigeration for a maximum of seven days, 9.1. Protocol: a room reserved for receiving and shall be frozen thereafter; samples and entering them into the records, and 5.2. Samples must be stored in a freezer at for issuing and filing results. -20ºC for thirty days for the confirmation test. 9.2. Testing room: a room where samples 6. BIOSECURITY will be processed. It should have a waterproof 6.1. Individual protective equipment (IPE) is counter resistant enough to stand disinfection, recommended while laboratory activities are be- washable walls and sufficient, adequate power ing carried out. supply outlets for the operation of equipment. 6.2. As samples fall into the A category of solid 9.3. Washing and sterilization room: a room residues (National Environmental Council’s Resolu- provided with power supply outlets, and tanks tion No.5 of August 5, 1993, published in the Offi- or sinks for washing and sterilizing the material 279 cial Gazette no. 166 of August 31, 1993), they must used in the performance of diagnostic tests. Wall be autoclaved at 120ºC for thirty minutes under surfaces must be washable. one-pound pressure before being discarded. Cur- 10. TECHNICAL PROFESSIONAL IN CHARGE rent biosecurity norms should be complied with. OR DEPUTY 7. RESULTS AND REPORTS 10.1. The technical professional(s) in charge 7.1. Test results must be released on appro- must be qualified for test performance under the priate forms, pursuant to item 4.2 hereunder and protocol established by CLA herein. to an established flowchart. 10.2. For the purposes of a laboratory’s ac- 7.1.1 POSITIVE RESULT: should be promptly creditation and monitoring, the professional(s) in and confidentially communicated to the Animal charge shall be subject to technical auditing by Health Service/Section/Sector (SSA) of the Federal CLA auditors, through test performance monitor- Agriculture Office-DFA in the State where the re- ing at their respective laboratory. active animal located. The pertinent service/sec- 10.2.1. As an alternative, qualification exams tion/sector shall officially notify the interested will be held at units of the CLA/MAPA laboratories party. The local DFA may determine that notifica- network, pursuant to criteria and schedule estab- tion be sent directly to the executing body. lished by CLA. 7.1.2. NEGATIVE RESULT: should be commu- 11. PERFORMANCE OF CONFIRMATION TESTS nicated to the veterinarian who signed the test 11.1. Confirmation tests shall be performed solely at the laboratory that did the first tests. jected to any ethical proceedings. 11.2. Confirmation tests must be applied for 12.5. Copy of his and/or his deputy’s CRMV by the interested party (pursuant to form shown in professional registration card. Annex VI) within eight days as of receipt of results. 12.6. Documents pertaining to the qualifica- 11.3. Confirmation tests must be applied for tion of the technical professionals (senior and his to the SSA/DFA of the state where the reactive ani- deputy): qualification certificate issued by MAPA mal is located. SSA/DFA shall notify the laboratory and CLA’s audit report. that did the first test, setting the date and hour 12.7. Current registration as legal entity for the performance of the confirmation test. An (CNPJ). SSA/DFA technician may attend and inspect the 12.8. Plan or sketch of the laboratory facili- testing and check the result. ties, indicating the position of the equipment re- 11.4. Absence of an SSA/DFA representative quired for accreditation. shall not prevent the performance of confirma- 12.9. Copy of the current operation permit tion tests, provided the dispositions under the issued by the competent local Sanitary Authority, preceding item are complied with. specifying the activities for which the laboratory 11.5. Samples for confirmation test should is qualified. be kept for a minimum of thirty days as of issu- 12.10. Operation permit issued by a senior ance of the result, to be available to MAPA upon authority, in the case of an educational and/or request. research institution. 11.6. It shall be incumbent on the veterinari- 12.11. Quality and Technical Procedures an that has requested the confirmation test to at- Manuals. tend it and to check the accuracy of the result(s). 12.12. Statement by the senior professional 11.7. The result of a glanders confirmation in charge and his deputy to the effect that they test shall be issued in a new application and are familiar with the current legislation on ac- result notification form, and forwarded as de- creditation and monitory of glanders diagnostic scribed under 7.1. above. laboratories. 11.7.1. The seal number and the record 12.13. List of employees involved in the number must be entered in the form’s slot for analysis subject to accreditation, their employee observations to identify the test as a confirma- status, and work schedule. tion test. OBSERVATION: 280 11.8. Should the requesting veterinary or his (1) In the case of a technical professional deputy waive the performance of a conformation in charge and/or his deputy working in a labo- test in a written statement or by failing to attend ratory belonging to third parties, the application the confirmation test, the result of the first test documents must be issued by the laboratory’s shall prevail. owner, director and/or professional in charge. 12. DOCUMENTS REQUIRED FOR ACCREDI- (2) In case the qualification test is - per TATION formed at the same time as the audit, all the req- 12.1. Accreditation application submitted by uisite documents must be handed to the auditor the enterprise’s legal representative. in charge, who will forward them to the accredi- 12.2. Filled-out Laboratory Registration tation unit. form. 12.3. Resume of the technical professional I – PROCEDURES in charge and/or his deputy (activities related to accreditation). 1. INTRODUCTION 12.4. Statement from the Regional Veterinary Complement fixation consists in a chosen Medicine Council-CRMV with which the applicant glanders serologic method, as it is a highly sensi- and/or his deputy is registered, to the effect that tive, specific test according to OIE. he is current with his obligations and is not sub- This technique detects almost only IgG1 antibodies, which are specific to the infection. An an- Vortex mixer tiserum test is titrated through serial dilution and (*) Optional equipment a fixed antigen quantity is added to each well. If 3. GLASSWARE AND UTENSILS the antibody is present in the antiserum, immune Pan for ice bath – approximately 44 cm x 30 complexes are formed. The complement is then cm x 08 cm added to the solution. At this stage, antigen, test Cuvette for reagents serum, and complement react together. If com- Test tube rack plexes are present, the complement is activated Gauze and is fixed and consumed. At the reaction’s final 96-well round-bottom microtitre plates stage, the indicator cells (erythrocytes), together Rectangular filter paper with a sub-agglutinating quantity of antibody (anti- Contact or aluminum paper erythrocyte antibody), are added to the mixture. di-Log milimeter paper If there is any remaining complement, these cells Monochannel pipette – 100 to 1,000 µl will be lysed; if the complement has been entirely Multichannel pipette – 10 to 200 µl consumed in the preceding stage, the cells will not Glass pipettes – 1 mL be lysed, owing to insufficient quantity of comple- Glass pipettes– 10 mL ment in the solution. The quantity of complement Glass pipettes – 2 mL (1:10 scale) used will be sufficient for lysing indicator cells only Glass pipettes – 2 mL (1:100 scale) if none of the complement is consumed. Glass pipettes – 5 mL Under this method, adequate controls are Bulb or automatic pipeting device vitally important because some antibody prepa- Disposable pointers for automatic pipeting rations consume complement without the addi- device tion of antigen, as is the case with serums that 100 mL test tubes already contain immune complexes. Some anti- 15 mL millimeter conic test tubes (for cen- gens may also have an anti-complement activity. trifuging) Thus, controls should include only antibody and 50 mL conic test tubes (for centrifuging) only antigen to find out if none of them by itself 13 x 150 mm test tubes is fixing complement. The result of the Comple- 18 x 180 mm test tubes ment Fixation test is based on the percentage of 10 x 70 mm test tubes sensitized erythrocytes hemolysis. 10 x 50 mm test tubes 281 2. EQUIPMENT 250 mL and 1,000 mL Flat-bottom flasks Microplate shaker 50 mL, 250 mL, and 1,000 mL Erlenmeyer Autoclave flasks Scales 4. SOLUTIONS Bain-marie: 58ºC Trietanolamin or Veronal concentrated Bain-marie: 62ºC solution Bain-marie: 37ºC Trietanolamin or Veronal working solution Centrifuge (900 x g) for 15 mL tubes Distilled water Centrifuge (900 x g) for 50 mL tubes 5. SAMPLE RECEPTION AND PREPARATION Refrigerated centrifuge* The Complement Fixation test detects anti- Distiller bodies only in serum. Plasma is not acceptable Digital spectrophotometer (540 mm range) for this test. The serum must be of good qual- Reading mirror* ity and free of bacterial contamination and ex- Bacteriological oven: 37ºC cessive hemolysis. Samples must be properly Freezer: -70ºC* identified in the tubes by the animal’s name or Refrigerator number. They must be forwarded refrigerated or Potentiometer frozen, if centrifuged, and packed in Styrofoam 60-minute timer containers with ice. Test samples and the control serum (high tion, and centrifuge at 900 x g for 10 minutes. and low positive, and negative) will be diluted 3. Remove the floating solution by suction. at 1:5 in the working solution (125 µl serum + Add working solution to the tube, gently mix by 500 µl). inverting the tube, suspending the erythrocyte Equine samples and controls must be in- again, and centrifuge it again at 900 x g for 10 activated in bain-marie at 58ºC for 35 minutes. minutes. Mule, donkeys, and pregnant mare samples 4. Carefully remove the floating solution must be inactivated at 62.5ºC for 35 minutes. and leucocytes by suction. Add working solution After the inactivation period, samples to suspend the erythrocyte again, and transfer should be removed and left at room tempera- it to a 15 mL volumetric centrifuge tube. Gently ture if they are going to be immediately tested; mix and centrifuge it again as before. otherwise, they should be kept at 4ºC for a max- 5. Check the color of the floating solution. If imum of 24 hours. it has color, discard the erythrocyte and repeat Preparation and washing of red blood cells the initial procedure with a new erythrocyte. (RBCs) 6. Carefully remove the floating solution by Determine the volume of red blood cells suction without destroying the cells. Check the necessary for a 2-percent suspension: final erythrocyte volume. For preparing the color standard, 12.0 7. Calculate the quantity of diluter needed mL of 2% RBCs will be necessary. Determine if for re-suspending the erythrocyte. For each 1.0 hemolysin titrating is necessary. If it is, increase mL of compacted erythrocyte, add 34 mL of di- the volume of 2% RBCs to 36.0 mL; luter. For titrating complement, increase volume 8. Standardization of erythrocyte at 2%: to 12.0 mL; Turn on the spectrophotometer before- For the diagnostic test, add 2.0 mL for se- hand, as per maker’s instructions. rum titration, and 1.2 mL for each screening Carefully pipet 1.0 mL of the erythrocyte test serum. suspension into a volumetric flask containing Calculate the total volume of 2% RBCs nec- 25 mL of Drabkin’s solution. Mix well, by invert- essary for the following stage: ing the tube ten times to lyse the cells. Set the 1. Ignore floating solution (Alserver). Wash device to the cyanmethemoglobin standard, RBC three times with diluter. with a 540 nm wavelength. Calculate the final 282 2. Filter the preserved blood in sterile gauze cell suspension volume, by employing the fol- into a 50 mL centrifuge tube, add working solu- lowing formula:

Final (test suspension optical density-OD) x (original volume of the 1 mL test suspension) Volume = target optical density-OD for an erythrocyte suspension at 2%

Dilute suspension with diluter in the esti- Prepare a 1:100 dilution of the stock Drab- mated quantity. kin’s solution in distilled water. This solution remains stable for at least six months in a dark Reagent and Cyanmethemoglobin (CMH) flask. Discard it if it shows cloudiness or precipi- standard. tates. (b) Hemoglobin Standard (HS): (a) Drabkin’s Solution (DS): Pepare an HS solution by adding 0.1 mL of HS to 12.5 mL of Drabkin’s solution and mix well. concentrations of 80, 60, 40, 20, and 0 mg%. (c) Prepare the CMH Standard: Add DS and HS to the tubes as follows: Label five 12mm x 100mm tubes for standard CMH Concentration (mg %)

80 60 40 20 0 HS (mL) 4.0 3.0 2.0 1.0 0.0 DS (mL) 0.0 1.0 2.0 3.0 4.0

Set the spectrophotometer to zero with a tube with 0.0 mg% of CMH. Proceed to three readings of the optical density (OD) in each tube. Set the apparatus to zero for each time period and estimate the readings’ average. (d) Estimate the target’s optical density:

CHM Concentration OD Readings 80 0.492 60 0.369 40 0.246 20 0.128 200 1.236

Instrument factor = 200 mg% = 161.81 mg%/OD 1.236

283 Each target OD of sheep cell suspension is the CMH mg% standard divided by the instrument factor. The mg% CMH standard is the average for a pool of sheep erythrocytes.

Lamb cell suspension (%) CMH mg% Standard 2.0 25.03 2.8 35.04 3.0 37.54

Example: Target OD for suspension at 2%: 25.03 = 0.15 161.81 Color standard 2. Preparation of erythrocyte solution at 4%: 1. Preparation of the Hemoglobin (Hg) Solu- Add 24.0 mL of the working solution to the tion: Erlenmeyer solution. Add 18.0 mL of distilled water to Erlenmeyer Add 6.0 mL of the erythrocyte suspension at solution 2% to obtain a 4% erythrocyte suspension. Add 6.0 - mL of the erythrocyte suspension Mix gently by inversion. at 2% 3. Color standard Mix in vortex mixer until cell is completely Label 13 serologic tubes (10 mm x 50 mm) lysed. at the hemolysis rate shown in Table 1 below. La- Add 6.0 mL of the mother solution. bel the 0% standard with the date and time of Mix the hemoglobin solution and put aside preparation. until use.

Table 1: 0% 10% 20% 25% 30% 40% 50% 60% 70% 75% 80% 90% 100% Hg 0 0.4 0.8 1.0 1.2 1.6 2.0 2.4 2.8 3.0 3.2 3.6 4.0 Cel 4.0 3.6 3.2 3.0 2.8 2.4 2.0 1.6 1.2 1.0 0.8 0.4 0

Mix tubes in vortex mixer and centrifuge 900 The work with complement requires ice bath x g for 10 minutes and proceed to OD reading. throughout. Store at 4ºC until time for use. Add 9.0 mL of working solution to a 13 mm 4. Preparation of sensitized blood cells x 150 mm tube. (RBCs) Take out a portion of C’ from the -70ºC or (a) Add 12.0 mL of erythrocyte at 2% to a 50 -20ºC freezer mL flask. Take 1.0 mL of C’, add to the working solu- Prepare an hemolysin dilution from the tion, and gently mix to obtain a 1:10 complement 284 stock 1: 10 dilution. Let solution stabilize for 20 minutes. Add 12.0 mL of the solution resulting from Prepare 1:500, 1:600, and 1:700 C’ dilutions. the above dilution to the erythrocyte solution. Dilutions indicated here are just examples and Mix rapidly. may vary according to the complement’s titra- Incubate for ten minutes in bain-marie at tion. Add working solution and C’ according to 37ºC. the following Table 2: Complement titration (C’) Table 2: Title C 1:10 DILUTER 200 0.4 7.6 250 0.3 7.2 300 0.3 8.7 400 0.3 11.7 500 0.3 14.7 600 0.3 17.7 700 0.3 20.7 Gently mix by inversion. indicated in Table 3. Let diluted C’ stabilize for 20 minutes. Add 1.6 mL of sensitized cells to each tube. Label three series of 10 mm x 50 mm tubes; Mix tubes in the vortex mixer and set in bain- one series for each C’ dilution. marie at 37ºC for 15 minutes. Add working solution to the tubes in the Remove the tubes and mix in vortex mixer. quantities indicated in Table 3. Replace tubes in bain-marie at 37ºC for an- Add diluted C’ to the tubes in the quantities other 15 minutes.

Table 3: REAGENT TUBE 1 TUBE 2 TUBE 3 TUBE 4 DILUTER 1.0 0.6 0.22 0.0 COMPLEMENT 1.0 1.4 1.8 2.2 HEMOLYTIC 1.4 1.4 1.4 1.4 SYSTEM

Remove tubes from bain-marie and centri- Draw a straight line connecting middle points. fuge 900 x g for 10 minutes. 4. Determine the line inclination angle Read optical density of tubes with 50 nm On any point of the straight line, measure a wavelength. 10 cm line to the right. Compare each tube of the series with the Measure the vertical line in mm from the color standard. end of the horizontal line to the middle points Determine the hemolysis percentage for inclined line. each tube. To obtain the inclination angle, measure the Draw a Logarithmic Chart: two middle points and mark the center. 1. For each series of four titration tubes, plot From this point, draw a line to axis Y. If the on a logarithmic paper the C’ volume in mL (axis inclination angle is 0.44 ± 20º, continue as de- Y) versus the corresponding hemolysis percent- scribed below. If the inclination angle is not with- age (axis X). in this range, repeat the titration of C’ with the 285 Tubes 1, 2, 3, and 4 correspond to logarith- reserved erythrocyte batch. mic numbers 3, 4, 5, and 6 on axis Y. Determination of the C’ dilution required for In addition, logarithmic numbers 3, 4, 5, and the diagnostic test: 6 on axis Y correspond to 0.3, 0.4, 0.5, and 0.6 mL From the middle point of the middle points, of C’ (Figure 1). draw a horizontal line to axis Y; 2. A chart is valid when two points are on Read the mL volume for the Chart. This vol- the left and two points are on the “50” verti- ume contains a 50% unit of C’ hemolysis (C’H50); cal line. A chart is also valid if a middle point Determine the volume containing 5.0 C’H50 crosses the “50” line. If all charts are invalid, by multiplying the volume contained in a C’H50 titration of C’ should be done again with differ- unit by 5 (5.0 C’H50 in 0.2 mL is the quantity ent C’ dilutions. needed for the diagnostic test). 3. On a valid chart, plot the tubes 1 and 2 Based on the valid chart, calculate the C’ di- points and mark the middle point. lution necessary for obtaining 5.0 C’H50 in 2.0 mL Repeat the procedure with points 3 and 4. through the following equation:

C’ dilution used in titration = dilution in the test Quantity of C’ used in titration C’ quantity used in the test Example: The C’ titration volume in the 1:500 C’ in the test is 0.2 mL (0.025 mL/well x 8 wells). The dilution is 2.15 mL (5.0 x 0.43 mL). The quantity of C’ dilution for the test is calculated as follows:

500 = X 2.15x = 500 x 0.2 = 100 2.15 0.2

x = 100 = 46.5 2.15

(0.6) 6

(0.5) 5

(0.4) 4 C’ volume in mL C’ volume

(0.3) 3

286 2

1 0.05 0.1 0.2 0.5 1 2 5 10 20 30 40 50 60 70 80 90 X Hemolysis percentage

Test performance Put the calculated solution volume in a small 1. Preparation of diluted C’ flask or test tube, depending on the quantity. Determine the volume of diluted C’ required Add the volume of C’1:10 in the flask with for the text, by multiplying the number of wells the working solution and gently mix. in the test by 0.025 mL. Keep this dilution at 4ºC. Let it stabilize for Calculate the volume of the working solution 20 minutes. and of C’1:10 containing 5.0 C’H50, as determined 2. Microplate labeling by the C’ titration. Serum titration plate: A 1:5 1 2 3 3 3 3 3 CH CL CN 0% 1 B 1:10 25% 2 C 1:20 50% 3 D 1:40 75% 4 E 1:80 100% 5 F 1:160 6 G 1:320 7 AC 9 8

3. Antigen preparation: 4.2. Addition of sensitized and non-sensi- Determine the required antigen volume by tized cells multiplying the number of wells receiving 0.025 Determine the volume of sensitized cells re- of antigen. Dilute the antigen at 1:125. quired for the test by multiplying the total num- Prepare the required working solution vol- ber of wells by 0.05 mL. ume and mix. Remove the 2% erythrocyte stored at 4ºC and Store the antigen solution at 4ºC until time gently agitate for re-suspension. to use. Add to a flask an erythrocyte volume equal 4. Adding reagents and samples to the to the volume of the working solution with di- plates: luted hemolysin. 4.1. Serum titration: Incubate in bain-marie at 37ºC for ten min- Add 25 µl of the test serum to the 1:10-1:320 utes. dilution wells and on the AC line. Remove the hemolytic system from the bain- Add 25 µl of the test serum to the 1:5 and marie. 1:10 dilution and AC line. Add 50 µl of sensitized cells to the 1:5-1:320 Add 25 µl of the control serums (high and dilution wells and the AC titration plates and the low positive and negative) to the 1:5, 1:10, and M and CC screening test columns. AC wells on the respective columns as shown Add 25 µl of the 2% erythrocyte to wells 7, 8, in Figure I. and 9 of the reagents control. 287 In a 25 µl diluter, mix the control serums 4.3. Addition of other reagents and incuba- and the test serums in the 1:10 titration wells for tion: four seconds. Transfer and mix serum in the suc- Add 125 µl of each color standard separately cessive dilutions to each well. At the last dilution to the wells labeled from 0 to 4+. (1:320), ignore 25 µl. Cover plates and mix for one minute. Add 25 µl of the diluted antigen to the 1:5- Incubate plates in an oven at 37ºC for 20 1:320 dilution wells. Add 25 µl of diluted C’ to the minutes. 1:5 to 1:320 dilution wells and on AC line. Remove plates and mix for re-suspending Reagents control (see Table 4). non-lysed cells. Mix plates for one minute. Cover plates to Incubate again for 25 minutes. minimize evaporation and incubate in an oven Centrifuge plates for 5 minutes at 300 x g, or at 37ºC for one hour. let rest for at least two yours in the refrigerator. Table 4 – Reagents Control WELL μl DIL μL Ag μl C’ μl SH μl H2% Results 1 25 25 25 50 0 2 50 25 50 4+ 3 50 25 50 0 4 50 25: 1/2 50 Traces at 3+ 5 25 25 25: 1/2 50 Traces at 3+ 6 75 50 4+ 7 100 25 4+ 8 75 25 25 4+ 9 75 25 25 4+

Antigen anticomplementary control Compare the reagents controls to determine 2 – If hemolysis occurs, there is a problem if they match the standards established in Table with the erythrocytes 4. If not, repeat the entire procedure. 3 – Free C’, total hemolysis Read the hemolysis percentage for each 4 – Check the strength of C’: 1+ is the ideal tested well. This percentage is based on the size, 5 – Antigen anticomplementary control if color of the floating element, and thickness of there is much C’ the bud, in order of their importance. 6 – Hemolysin control Sensitized cells should be completely hemo- 7 – Cells control lysed in the AC control. If not, the serum is con- 8 – Cells control sidered anticomplementary, and a new sample 9 – Cells in the presence of antigen should be requested. Interpretation of results The title entered into the records is the dilu- Read the results of the reagents’ controls, tion subsequent to the last complement fixation. comparing the percentage of hemolysis with If few cells remain in the well, the serum 288 the color standard. Interpret results on the ba- is considered inconclusive, and a new sample sis of Table 5 should be requested.

Table 5. Hemolysis percentage readings’ equivalency and numeric values Hemolysis Percentage Interpretation Diagnostic 0 4+ Positive 25 3+ Positive 50 2+ Positive 75 1+ Positive 100 Negative Negative

If few cells remain, the sample will be considered inconclusive. OBSERVATION: The report should be conclusive and contain the following information: NEGATIVE POSITIVE: Indicate the title found. INCONCLUSIVE: Requires new sample collection. ANTICOMPLEMENTARY: Requires new sample collection. ANNEX I

Hemolysin Titration: From 1:10 HL, make 1:1000 HL = 1mL 1:10 Wash erythrocytes: Calculate the required HL + 9.0 mL diluter. volume of 2% erythrocyte. Dilute 1:1000 HL = 18 mL diluter + 2.0 1:100. Wash three times at 900 x g for 10 minutes. Label 15 x 180 or 18 x 180 tubes for 1:1500, From pure hemolysin (HL), make a 1:10 dilu- 2000, 2500, 3000, 4000, 8000, and 16000. tion in an 0.85 saline solution. Dilute hemolysin according to the table below:

FINAL HL DIL. DIL (mL) HL 1:1000 mL 1:1500 1.0 2.0 1:2000 2.0 2.0 1:2500 3.0 2.0 1:3000 2.0 1.0 1:4000 3.0 1.0 1:8000 7.0 1.0 1:16000 15.0 1.0

Hemolytic System: in bain-marie at 37ºC for 10 minutes. Label 12 x 100 mm or 13 x 100mm tubes Prepare Complement (C’) at 1:200, 1:250, from 1:1000 to 1:16000 and place in each tube and 1:300. 2.0 mL of 2% H and 2.0 mL of HL dilution as in Label three series of tubes for reading the C’ the above table. dilutions in a spectrophotometer. Agitate each tube in a vortex agitator and set

0.8 mL dil 1/1000 – 1/1500 – 1/2000 up to 1/16000 – C’ 1/200 0.4 mL C’1/200 289 0.8 mL SH

0.8 mL dil 1/1000 – 1/1500 – 1/2000 up to 1/16000 – C’ 1/250 0.4 mL C’1/250 0.8 mL SH

0.8 mL dil 1/1000 – 1/1500 – 1/2000 up to 1/16000 – C’ 1/300 0.4 mL C’1/300 0.8 mL SH

Mix for shaking and set in bain-marie at 37ºC Recording the CS readings from the spectropho- for 30 minutes (agitate for 15 minutes). tometer. Draw the chart: Preparation of the color standard: On milimetered chart paper draw a 20 cm Prepare the color standard (CS) as in the (30 cm) straight line and mark the 1:1000 dilu- glanders test. Record the optical density values. tion. To calculate the other fractions, divide Centrifuge tubes at 900 x g for 10 minutes. 20.000 for each dilution. Example: squares (every 2.0 cm). 20000 = 13.3 Marking points: Read the optical density of 1500 the three c’ dilutions for all values, from 1:1000 From zero point (0), mark 13.3 cm. Calculate to 1:16000. Associate the optical density value up to 1:16000 dilution. to the hemolysis percentage CS. Mark the points On the vertical line, mark the hemo- and plot the graph. The optimum point will be lysis percentages from 10% to 100%, every two the one showing stability (Figure 2).

100

Hemolysis Percentage 20

0 32000 16000 8000 4000 3000 2500 2000 1500 1000

Hemolysin Dilution

290 Bibliographic References: United States Department of Agriculture/National Veterinary Services Laboratories - Testing Protocol. Complement Fixa- tion Test for Detection of Antibodies to Burkholderia mallei: Microtitration test. Ames, IA - April 30, 1997. ROITT, I; BROSTOFF, J; MALE, D. Imunologia. Editora Manole, 5th ed., 1999, 421 pp.

ANNEX II

SOLUTIONS AND REAGENTS Place in a 1-liter graduated flask: Trietanolamin buffer (TEA) – Mother solution 100 mL of mother solution Place in a 1-liter graduated flask: 0.5 g of gelatin in boiling water (Merck 4070) 28 mL of trietanolamin (Merck 108379) Measure pH, which should be between 7.3 180 mL of 1N chloridric acid (Merck PA 15893) and 7.4. Citric acid may be used to correct pH. 75 g sodium chloride (Merck 6404) Dissolve the sodium chloride in approxi- 1 g hydrated magnesium chloride (Mer- mately 600 ml of distilled water in a 1-liter volu- ck5833) metric flask. Add the other reagents in the order 0.2 g calcium chloride (Merck 2382) mentioned. Add distilled water to make one liter Trietanolamin is a very viscous liquid and Diluted trietanolamin solution – Working should be carefully measured by, for example, solution transferring it to a graduated cylinder with a glass rod or pipette, so that the trietanolamin in a recipient containing Alsever’s solution in do not touch the cylinder walls, up to 28 mL. the same quantity as the blood. The trietanolamin may also be weighed in a The mixture should be carefully shaken precipitate recipient (28 mL is equivalent to and distributed into 18 x 180 test tubes and re- 31.45 g). As the density of the different lots may frigerated. Use after five days. vary slightly, the required weight should be ad- Hemolysin (Amboceptor) justed. Whatever the method used, the recipi- This is a serum with a high titer of antibodies ent in which the trietanolamin was measured against sheep erythrocytes. When these antibod- should be completely rinsed with the solution ies are combined with erythrocytes in suspen- in the volumetric flask, to ensure that all the tri- sion, these erythrocytes are sensitized, i.e., they etanolamin has been incorporated into the di- are lysed in the presence of free complement. luter. The magnesium chloride and the calcium Hemolysin should be prepared only in chloride mother solutions should be prepared rabbits. Most works on serologic techniques just as the first diluter cited, but to a ten-times (Campbell et al., 1963 or Cruickshank, 1965) higher degree of concentration, i.e., 10 g of Mg- give details on the hemolysin preparation Cl26H2O yield 11.8 mL of 4.16 mol/L mother so- method. Hemolysin sold on the market is usu- lution and 10 g of CaCl26HO yield 54.4 of 1.25 ally in liquid form and is preserved in an equal mol/L mother solution. volume of glycerin. The diluted solution pH should be 7.3-7.4 at Complement 20ºC; each new batch of diluter with a concen- Bleed at least four rabbits, separate the se- tration of 1:10 should be measured before use. rum from clotting as soon as possible and mix Veronal buffer (mother solution) it to prepare the complement. Adult rabbits, Add 100 mL distilled in 250 mL of Erlen- well fed with fresh vegetables yield good qual- meyer. ity complement. The animals must not take Add 20.3 g of MgCl126H2O in any food for 12 hours. Pregnant or recently Add 4.4 of CaCl22H2O delivered females should not be used. The Mix gently complement should remain frozen at -40ºC or Store under refrigeration. at lower temperature, if this is done properly. Alsever’s solution The storage of liquid nitrogen is an effective, Glycose – 18.66 g practical means. The complement may be pur- 291 Sodium chloride – 4.18 g chased in cold-dried and or dehydrated form Sodium citrate – 8.0 g but even in this form it must be stored in a Citric acid – 0.55 g refrigerator or freezer. Distills water sufficient to make up 1000 mL Instructions: The solution should be sterilized in auto- 1. The slot assigned to “Observations,” should clave, after being filtered in a Seitz filter. Sheep contain information pertaining to the animal’s blood may be aseptically kept in the refrigera- history, any symptoms, contacts, transfers. tor in flasks with screw caps. It should not be 2. Report used before at least five days after bleeding and - Write the report as accurately as possible may be utilized for up to six weeks as long it has - Use blue or black ink pen not been contaminated. - Indicate whorl with a plain “x” on the site, Sheep erythrocytes stretching the line, which should end with an “R” Sheep erythrocytes should be chosen from - Indicate elongated whorls by a waving line one or more than one sheeps that produce - Indicate only the outline of spots, stars, or erythrocytes with a satisfactory, consistent de- foot spots gree of sensitivity and taken always from the - Never paint or fill out the outlines, shading same animals. the spot areas The blood should be aseptically collected - Two parallel lines on a member indicate that the member has no white spot between the nostrils. Should be indicated by the - Scars should be drawn word LADRE written out - Hoof: black - Neither write nor indicate - BETA is the pinkish spot on the lower lip anything. - If there is no discolored area (an area the White – Indicate with Br (for branco = color of the animal’s skin inside the LADRE or white) BETA, this should be indicated by AND. Mottled – Indicate with Rj (for rajado = - For pampa (pied) animals, indicate only mottled) the outline of the color areas, writing in inside White spot – should be indicated with MB the outline the color initial (B for branco, or (for mancha branca = white spot) white; C for castanho, or chestnut brown; A for - LADRE is the pinkish spot on the upper lip, alazão, or sorrel).

annex III

Seal of the laboratory accredited under Normative Instruction No/2003 GLANDERS DIAGNOSTIC TEST REQUEST AND RESULT NOTIFICATION FORM

Owner Property Property address/Contact address: No. State Register Telephone

Name: Species: Equine: Donkey: Mule: Breed: Age: Gender/Gestation: Registration No./mark: CLASSIFICATION Use: JC ES CR H BR MU Current location: 292 Pelage

Upper line of vision Right side Left side

Left Right Left Right

Neck/ lower Muzzle Front legs / Rear view view Hind legs / Rear view

Signs’s Description :

Observations: 293

OFFICIAL REQUESTER LABORATORY The animal was examined by me on this date: Test date: Result: Place and date Validity:

Veterinarian’s hand and seal Professional in charge’s signature and seal

JC: Jockey Club ES: Equestrian Society CR: Cancha reta H: Haras BF: Breeding Farm MU: Military Unit

OBSERVATION: A XEROX COPY OF THIS DOCUMENT IS NOT VALID. LEGEND:

R- Whorl Scar Br- White AND- area not discolored RJ- Motley LADRE- Pinkish spot (Upper lip) Pbs- White hairs BETA-Pinkish spot (Lower lip) MB- White spot Elongated whorl

ANNEX IV

RECORD LOG

Reg. Date Reference Sender Municipality/ Owner Property Animal’s Species Age/ Obs Seal Test Result Date Result State Name or gestation No. issued No.

ANNEX V

CONFIRMATION IDENTIFICATION CARD 294 CONFIRMATION IDENTIFICATION CARD

SEAL No. OBSERVATIONS:

SAMPLE No.

DATE

CARRIER LABORATORY REPRESENTATIVE ANNEX VI

Monthly Report of Activities

MINISTRY OF AGRICULTURE, LIVESTOCK AND Monthly Report on LABORATORY: FOOD SUPPLY ANIMAL AND PLANT HEALTH Glanders AND INSPECTION SECRETARIAT ANIMAL HEALTH AND INSPECTION DEPARTMENT ANIMAL LABORATORY COORDINATION

MONTH / YEAR Page:

State Municipality TOTAL Species Positive Negative Inconclusive Anti Total no. Total no. of Total No. complementary samples appropriated of tested received samples samples

295

TOTAL

No. OF PROPERTIES WITH CARRIER ANIMALS PER Signature and seal CLASSIFICATION JC ES H F MU OTHERS

JC: Jockey Club; ES: Equestrian Society; H: Haras; F: Farm; MU: Military Unit ANNEX VII

CONFIRMATION TEST REQUESTED

To SSA/DFA/ Laboratory: Address: I, ______, bearer of ID No. ______issued by ______(State) on ______(M/D/Y) hereby request the performance of a glanders confirmation test on sample No. ______pertaining to test Nº. ______. JUSTIFICATION:

Interested party’s signature:

Place and date ______, ____/____/____ (M/D/Y)

Aware by Professional in charge of the accredited laboratory.

COMPLEMENTARY LEGISLATION

296 ADMINISTRATIVE RULING No. 84 OF OCTOBER 19, 1992

Published in the Official Gazette of October 22, 1992 Section 1, Page 14874

Approves Norms for the Accreditation and Monitoring of Equine Infectious Anaemia Laboratories.

ADMINISTRATIVE RULING No. 200 OF AUGUST 18, 1981

Adds EIA to the list of diseases subject to the application of animal health and inspection measures (Decree No. 24548 of July 3, 1934).

DDA SERVICE INSTRUCTION No. 17 OF NOVEMBER 16, 2001

Determines the adoption of sanitary measures pertaining to the occurrence of equine influenza. NATIONAL SWINE HEALTH PROGRAM

NORMATIVE INSTRUCTION No. 8 OF APRIL 3, 2007

Published in the Official Gazette of October 4, 2007 Section 1, Page 1 Replaced by the Normative Instruction No. 22 of May 22, 2007

Approves the Rules for the Control and Eradication of Aujeszky’s Disease (AD) in domestic pigs, to be complied with all over the national territory

THE STATE MINISTER OF AGRICULTURE, LIVE- Aujeszky’s Disease in domestic pig, as provided STOCK AND FOOD SUPPLY, in accordance with the for in Annex I of this Normative Instruction, spec- duties and responsibilities assigned thereto by ifying the measures to be taken all over the na- Article 2 of Decree No. 5,741 of March 30, 2006, tional territory should the disease be detected in and according to the Judicial Proceeding No. pig, for the purpose of its prompt eradication. 21000.005409/2006-96, hereby resolves: Art. 3. To regulate the use and trade of Art. 1. To approve the Rules for the Control Aujeszky’s Disease vaccine all over the national and Eradication of Aujeszky’s Disease (AD) in do- territory. mestic pig, to be complied with all over the na- Art. 4. This Normative Instruction shall enter tional territory, as provided for in Annex I of this into force on the date of publication thereof. Normative Instruction. Art. 5. Normative Instruction DIPROD No. 01 Art. 2. To approve the Contingency Plan for of April 8, 1985 is hereby revoked.

REINHOLD STEPHANES

297 ANNEX I

RULES FOR THE CONTROL AND ERADICATION OF AUJESZKY’S DISEASE (AD) IN PIGS

CHAPTER I II – Aujeszky’s Disease (AD) means the dis- DEFINITIONS ease caused by a herpesvirus. Also known as pseudorabies, the disease, which affects several Art. 1. For the purpose of these Rules, the animal species causing nervous complications in following words and terms shall have the follow- piglets, respiratory problems in adult pig and de- ing meaning: livery complications in pregnant sow; I – Sanitary Slaughter means the slaughter III – Rearing establishments means the of infected animals or their direct and indirect places where pig are kept or bred for any purpose contacts pursuant to the legislation in force, whatsoever; performed at a slaughterhouse recognized by IV – Outbreak means the Rearing establish- the Brazilian System of Inspection of Products ment or any other place where the AD virus has of Animal Origin; been isolated or detected, or a positive serology result (total antibodies or antibodies against the XIII – Prevalence means the total number of viral glycoprotein gE, in those rearing establish- animals infected at a given time, divided by the ments where vaccination is carried out) has been total number of animals running the risk of get- confirmed by an Accredited Laboratory or by the ting the infection at the same time; National Agriculture and Livestock Laboratories; XIV – Owner means any natural person or V – Accredited Swine Breeding Farm (ASBF). legal entity that owns one or more pigs; means the establishment officially certified and XV – Herd means de group of pigs raised monitored according to the legislation in force, under common management conditions, in the where pigs are bred or kept for the purpose of same rearing establishment; trade or distribution and whose final product is XVI – Sacrifice and destruction means the intended for reproduction; operation carried out by the Official Veterinary VI – Interdiction means to prohibit, at the Of- Service when the occurrence of AD has been con- ficial Veterinary Service discretion, pig and other firmed. It consists in killing all the animals in the animals as well as people or materials that could herd that have tested positive for the disease and, be potential carriers of the disease from entering if necessary, other herds that have been exposed into and exiting a rearing establishment for any to direct or indirect contact with the AD virus as purpose whatsoever; well as destroying their carcasses; VII – Accredited laboratory means the pub- XVII – Official Veterinary Service means the lic or private laboratory that is granted by the body responsible for animal sanitary health and competent authority of one of the three levels of inspection activities at any of the three levels; authority that form the Agriculture and Livestock XVIII – Pigs means any animal of the Sus Health Care Unified System, the accreditation to scrofa domesticus (pigs) and Sus scrofa scrofa (Eu- make AD diagnosis as set forth by the Ministry of ropean wild pig) families; Agriculture, Livestock and Food Supply the Cen- XIX – AD infected pig means any pig with tral- and Higher-level Authority; clinical symptoms or signs consistent with AD, VIII – National Agriculture and Livestock with a diagnosis confirmed by tests carried out in Laboratories means the official laboratories of official or accredited laboratories; the Ministry of Agriculture, Livestock and Food XX – ADV infected pig means any pig with Supply; no clinical signs or injuries consistent with AD, IX – Accredited Veterinarian means the pri- but that has shown a positive reaction to the 298 vate sector professional accredited by an entity lab test carried out in an official or accredited of one of the three levels that form the Agricul- laboratory; ture and Livestock Health Care Unified System to XXI – Downtime means the period when perform specific animal sanitary and Inspection a rearing establishment stays empty following activities aimed at the rearing of pig, as set forth cleaning and disinfection; by the Ministry of Agriculture, Livestock and Food XXII – Aujeszky’s Disease Virus (ADV) means Supply, in its capacity as the Central- and Higher- the AD etiological agent of which pigs are the sole level Authority; natural host. In pig, the virus can survive in the X – Official veterinarian means a profession- form of unapparent infections and be reactivated al of the Official Veterinary Service; by transmission to susceptible pig; XI – Contingency Plan means a set of pro- XXIII – Zone Free of AD means a zone or re- cedures to be adopted should a outbreak occur, gion in a country where the absence of AD has for the purpose of controlling and eradicating the been systematically determined, in accordance AD agent; with the recommendations of the Terrestrial Ani- XII – Breeding Stock means the group of animal Health Code of the World Organization for mals, both male and female, used in a breeding Animal Health (OIE), and where vaccination has establishment for reproduction purposes; been prohibited for at least two (2) years; and XXIV – Zone temporarily free of AD means and the legislation in force. the zone or region in a country where AD out- Art. 5. Prior to developing a State Plan for breaks affect less than 1% of the pig herd and less the Control and Eradication of AD, the Interme- than 10% of the existing rearing establishments, diate-level Authority should assess the situation according to the recommendations of the Terres- for the disease, based on serum epidemiological trial Animal Health Code of the World Organiza- investigations carried out in those rearing estab- tion for Animal Health (OIE). lishments with a history of AD outbreaks and of the use of vaccines, as well as in other locations CHAPTER II somehow linked to these establishments. Art. 6. As a basic condition for preparing the OBJECTIVE State Plan, the Unit of the Federation should, after having fulfilled the provisions of Art. 5, re- Art. 2. The objective of these Rules is to lay quest that the Ministry of Agriculture, Livestock the foundation for implementing coordinated and Food Supply, as the Central- and Higher-lev- actions in each Unit of the Federation participat- el Authority, take the necessary steps for carrying ing in the Agriculture and Livestock Health Care out a serum epidemiological inquiry into the lo- Unified System, with a view to Controlling and cal epidemiological situation for AD (presence or Eradicating AD in domestic pig. absence of ADV). Sole Paragraph. Compliance with the provi- Paragraph 1. The sampling design shall be sions contained herein and in the Terrestrial Ani- determined by the Ministry of Agriculture, Live- mal Health Code of the World Organization for stock and Food Supply, taking into account the Animal Health will enable the Ministry of Agricul- pig populations from different productive strata ture, Livestock and Food Supply, as the central- (technified and subsistence rearing establish- and higher-level authority, to recognize a Unit of ments) and using a minimum estimated preva- the Federation as a zone temporarily free of AD lence of 1% of infected establishments and 5% or a zone free of AD. in rearing stocks, with a confidence level of 95%, according to the table shown in Art. 23. CHAPTER III Paragraph 2. Based on the analysis of the serum epidemiological inquiry results, the Inter- BASIC AND SPECIFIC CONDITIONS mediate-level Authority in the Federative Unit 299 shall propose the most suitable action strategy Art. 3. The activities to control and eradi- for the situation and its position in the State Plan cate AD are coordinated by the Ministry of Ag- for the Control and Eradication of AD. riculture, Livestock and Food Supply as the Cen- Art. 7. The State Plan shall meet certain spe- tral- and Higher-level Authority, and should be cific conditions such as: implemented with the voluntary participation I – the existence of an active state-level com- of the Federative Unit as the Intermediate-level mittee on swine health, with the preparation of Authority. minutes of meetings that should be forwarded Art. 4. The Units of the Federation inter- to the Federal Superintendency of Agriculture, ested in participating should prepare a Sate Plan Livestock and Food Supply, as the Central- and for the Control and Eradication of AD, which will Higher-level Authority; then be submitted for approval to the Ministry II – to have public or private funds to fi- of Agriculture, Livestock and Food Supply as the nance the Plan and compensate pig owners that Central- and Higher-level Authority. are affected by the sanitary measures resulting Sole Paragraph. The Federative Unit that from the implementation and maintenance of fails to submit a State Plan shall not be exempt- the actions provided for in these Rules and in the ed from adopting the AD Contingency Plan, pur- State Plan; suant to Annex II of this Normative Instruction III – to have Rules that are complementary to the federal legislation, so as to support Plan Art. 10. Units of the Federation that have actions within the Intermediate-level Authority; been certified by the Central- and Higher-level IV – to submit a sanitary education project Authority as free or temporarily free of AD should aimed at raising popular awareness of the State implement a serum epidemiological monitoring Plan for the Control and Eradication of AD to be system on a yearly basis, covering all swine rear- implemented; ing establishments that pose a risk, and carry V – to have an emergency group appropri- out periodic investigations based on samples ately trained to carry out sanitary health and collected by the inspection service from swine inspection actions in swine, as well as other ac- slaughterhouses, so as to contribute in sustain- tions resulting from the enforcement of these ing this sanitary condition. Rules and the State Plan; and VI – have a well structured animal sanitary CHAPTER IV health and inspection service within the Inter- mediate- and Local-level Authorities. DIAGNOSIS Art. 8. The development of the State Plan for the Control and Eradication of AD will be Art. 11. Diagnosing AD in pig will include periodically reviewed through audits to be performing serological tests of Enzyme-linked performed by the Central- and Higher-level immunosorbent assay (screening ELISA or differ- Authority in the Intermediate- and Local-level ential ELISA for the viral glycoprotein gE, in those Authorities. establishments where vaccination is adopted) Sole Paragraph. The Official Veterinary Ser- and the Neutralization Test, which are performed vice of the Federative Union that has in place a exclusively in official or accredited laboratories. State Plan for the Control and Eradication of AD, Paragraph 1. Samples of the brain, spleen, should submit to the Central- and Higher-level lungs and aborted fetuses may be submitted to Authority a quarterly report on the actions car- a virus isolation attempt or to molecular tests ried out in the period. (polymerases chain reaction - PCR). Art. 9. The region that succeeds in imple- Altered by Administrative Ruling 022 of menting a State Plan for the Eradication of AD 05/22/2007. should be subject to a new serum epidemiologi- Paragraph 2. Other diagnostic tests may be cal inquiry as provided for in Art. 5, in order to used provided that they are approved by the Min- 300 request the certification as a zone free or tempo- istry of Agriculture, Livestock and Food Supply as rarily free of AD from the Ministry of Agriculture, the Central- and Higher-level Authority. Livestock and Food Supply, as the Central- and Art. 12. Manipulation of the AD virus is Higher-level Authority, provided that the other prohibited all over the national territory, except rules of the International Zoosanitary Code of in official or accredited laboratories or institu- the World Organization for Animal Health have tions previously authorized by the Ministry of been complied with. Agriculture, Livestock and Food Supply as the Sole Paragraph. Where the presence of viral Central- and Higher-level Authority, provided activity is not detected during the initial serum that these have an appropriate level of biosafe- epidemiological inquiry into the epidemiologi- ty to contain the ADV. cal situation for AD, the Unit of the Federation Sole Paragraph. Only the aforementioned that meets the provisions contained herein as establishments can own AD diagnosing kits. well as the requirements of the World Organiza- Art. 13. The competent authorities at the tion for Animal Health may request immediate three levels shall accredit laboratories as de- certification as a zone free or temporarily free termined by the Ministry of Agriculture, Live- of AD from the Ministry of Agriculture, Livestock stock and Food Supply, which will establish and Food Supply, as the Central- and Higher- the requirements to be met for obtaining the level Authority. accreditation. CHAPTER V strategy or strategies for using the vaccine as follows: VACCINATION OF PIGS I – Use of the vaccine is prohibited in the Federative Unit; Art. 14. Only vaccines (inactivated or live II – Use of the vaccine is permitted only dur- attenuated) deleted at least for the viral glyco- ing sanitary emergencies resulting from the oc- protein gE, as well as diagnosis kits that enable currence of an outbreak, so as to contribute to identifying antibodies against this specific viral the sanitation thereof; and particle are permitted in the country. In addi- III – Use of the vaccine is permitted for the tion, both should be duly licensed at the Ministry purpose of reducing prevalence in endemic re- of Agriculture, Livestock and Food Supply as the gions, for a limited time and under the control of Central- and Higher-level Authority. the Official Veterinary Service. Art. 15. Vaccination is only permitted in those establishments with a positive diagnosis for CHAPTER VI AD made by an official or accredited laboratory. Sole Paragraph. Rearing establishments re- SURVEILLANCE AND INFORMATION lated to the outbreak establishment, as well as SYSTEM those where there is a risk of infection may, at the discretion of the Official Veterinary Service, Art. 18. The Official Veterinary Service shall vaccinate their animals against AD. maintain a zoosanitary surveillance and infor- Art. 16. The Central- and Higher-level Au- mation system covering all levels of authority, thority in the Federative Unity should have some including a systematic analysis of the data col- form of control over all vaccine doses used in lected and the preparation of periodic reports to their scope of action, with due regard to the fol- meet the requests of the Ministry of Agriculture, lowing criteria: Livestock and Food Supply as the Central- and I – The Central and Higher-level Authority in Higher-level Authority. the Federative Unit shall officially authorize sale Art. 19. Every veterinarian, owner, holder of the AD vaccine by the manufacturing labora- and transporter of animals or any other citi- tory or its legal representative, which should in- zen who learns about a possible outbreak of dicate the name and address of the owner(s) and AD or of diseases with a similar clinical picture 301 the number of doses; should immediately notify the Official Veteri- II – The manufacturing laboratory or its le- nary Service. gal representative shall sell the vaccine directly to Paragraph 1. Violations of the provisions of the indicated owner(s) and immediately send to this Article will be investigated accordingly by the requesting Federal Superintendency of Agri- the Official Veterinary Service, which will lodge culture, a copy of the corresponding invoice; a complaint against the offender with the Public III – In no way the sale of vaccines by the Prosecution Service, so that the appropriate li- manufacturing laboratory can be made through ability can be assessed. a dealer or retail network; and Paragraph 2. Where the offender is a vet- IV – On a monthly basis, the Federal Super- erinarian, a complaint against such professional intendencies of Agriculture will submit to the shall be lodged with the Regional Council of Vet- Ministry of Agriculture, Livestock and Food Sup- erinary Medicine where he/she is registered, so ply a report indicating the owners’ names and that the appropriate measures can be taken. the number of vaccines used within their scope Paragraph 3. Where the offender is an ac- of action. credited veterinarian, in addition to the provi- Art. 17. By assessing the epidemiological sions of paragraph 1 and 2 above, the Official situation of the region for AD, the Intermediate- Veterinary Service shall proceed according to level Authority may propose in its State Plan a the specific legislation. CHAPTER VII Paragraph 2. The table should be used independently for rearing stock and fattening animals. STRATEGIES FOR ACTING ON AD OUTBREAK Art. 24. In an AD outbreak, the Official Veter- inary Service may, based on the results of either Art. 20. All suspected AD outbreaks AD the serology tests or the estimated degree of herd should be investigated by the official veterinarian, infection and as provided for in the State Plan, no later than twelve (12) hours after notification use one of the following sanitation strategies: thereof, with due regard for biosafety procedures. I – Immediate depopulation; Art. 21. The confirmation by the official vet- II – Gradual depopulation; and erinarian of a suspected case of AD in a rearing III – Eradication by serology. establishment shall imply the immediate inter- Art. 25. In the AD eradication methodology diction thereof. by immediate depopulation, the rearing establish- Art. 22. The confirmation by a laboratory ment will go through immediate sanitation proce- of a suspected case of AD in a rearing estab- dures as a result of the sacrifice and slaughtering lishment shall imply the immediate adoption of the whole swine herd, regardless of the age and of measures for sanitation of the outbreak and physiological state of the females in the herd, with prevention of dissemination to other rearing an emphasis on the following sanitary measures: establishments as provided for in these Rules I – The loading of pig should be followed by and in the AD Contingency Plan (Annex III). the Official Veterinary Service, which will seal the Art. 23. A serum epidemiological investi- transportation vehicle and include the seal num- gation shall be carried out in rearing establish- ber in the transit document; ments located within a minimum radius of five II – The rearing establishment will comply (5) kilometers from the outbreak as well as in with a downtime of at least thirty (30) days af- other properties related to the outbreak within ter the last animals have been removed from the a minimum period of thirty (30) days prior to the herd; and diagnosis, at the discretion of the Official Veteri- III – The sanitary slaughter should take place nary Service, with a view to determining the ori- in a swine slaughterhouse recognized by the Bra- gin and dissemination of the infection. zilian Animal Products Inspection System. Paragraph 1. To evaluate the sanitary situation Art. 26. In the AD eradication methodology of a rearing establishment regarding AD, the official by gradual depopulation, the herd should be 302 veterinarian shall collect samples from swine and sanitary slaughtered within a maximum period send such samples to the official or accredited labo- of ninety (90) days from the diagnosis, based on ratory for the purpose of diagnosis, using the mini- the following principles: mum estimated prevalence of 5% and confidence I – Immediate sanitary slaughter of pigs de- level of 95%, according to the table below: termined to be infected; II – Vaccination of herd seven (7) years of age HERD SAMPLED ANIMALS and older, until depopulation of the rearing establishment has been completed, so as to avoid 1-25 ALL dissemination of the clinical disease; 26 - 30 26 III – Immediate sanitary slaughter of non- 31 - 40 31 pregnant sows, sows up to the 60th day of preg- 41 - 50 35 nancy and replacement sows; IV – Immediate castration of boars, which 51 - 70 40 should be sent for sanitary slaughtering when 71 - 100 45 in good conditions, pursuant to the legislation 101 - 200 51 in force; 201 - 1200 57 V – Lactating sow should wait until the weaning period is over and then be sent for sanitary Above 1200 59 slaughtering when in good conditions, pursuant Art. 28. When authorized by the Official Vet- to the legislation in force; erinary Service, the repopulation of the rearing VI – Sow sixty (60) days pregnant or more establishment(s) shall be carried out with ani- should wait for delivery, in which case the provi- mals originating in ASBF. sions of item V will apply; Sole Paragraph. Fattening establishments VII – Piglets in nursery or crèche should be should be repopulated with animals originating sent for sanitary slaughtering at approximately in rearing establishments that have tested nega- twenty three (23) kilos of live weight; tive for ADV in a test carried out at an official or VIII – The loading of pigs should be followed accredited laboratory, based on the sampling by the Official Veterinary Service, which will seal shown on the table of Art. 23. the transportation vehicle and include the seal Art. 29. Rearing establishments submitted to number in the transit document; any of the control and eradication strategies de- IX – Disinfection will take place as provided scribed in Articles 25, 26 and 27 should have their for in the Contingency Plan (Annex II) and the AD-free condition confirmed by two (2) consecu- rearing establishment will comply with down- tive negative serologies at two-month intervals time of at least thirty (30) days after the last ani- carried out independently for the rearing stock mals have been removed from the herd; and fattening animals, based on the sampling X - The sanitary slaughter should take place shown on the table of Art. 23. in a swine slaughterhouse recognized by the Bra- Sole Paragraph. The first serology should be zilian Animal Products Inspection System; and carried out immediately after the parturition of XI – Piglets in the fattening stage should be the first batch of sows introduced. sent for sanitary slaughter when they reach the optimal weight. CHAPTER VIII Art. 27. In the AD eradication methodology by serology, the rearing establishment shall be TRANSIT OF PIGS AND OTHER MATERIALS submitted to periodic serological tests that are capable of telling if the humoral titers result from Art. 30 . The transit of pigs vaccinated against the infection by ADV or from the vaccination pro- AD for any purpose is prohibited, except for imme- cess, with a gradual elimination of the animals diate slaughter in slaughterhouses recognized by that tested positive for AD as follows: the Brazilian Animal Products Inspection System. 303 I – Scrifice or Sanitary slaughter of the ini- Paragraph 1. Where he rearing establish- tially infected animals; ment does not have sufficient stocking capacity, II – Vaccination of herd seven (7) years of it may be authorized, at the discretion of the Of- age and older, so as to avoid dissemination of the ficial Veterinary Service, to transfer piglets to be clinical disease, to be suspended at the end of fattened in another establishment, provided that the process, at the discretion of the Official Vet- this is located in the same Federative Unit where erinary Service; the pig will be kept under supervision until they III – New serology of the whole rearing stock reach the optimal slaughtering weight. thirty (30) days after the infection was detected in the Paragraph 2. Transit should take place in a ve- herd, with immediate sanitary slaughter of the in- hicle sealed by the Official Veterinary Service and fected animals, pursuant to the legislation in force; accompanied with the transit document issued by IV – Repetition of serologies in 100% of the an official veterinarian containing the seal number stock, with 60-day intervals between the tests, as and the indication of vaccinated against AD. provided for in item III above, until two consecu- Paragraph 3. The rearing establishment of tive negative serological results are obtained; and destination of vaccinated animals shall adopt V – The sanitary slaughter should take place the same restriction conditions as those of the in a swine slaughterhouse recognized by the Bra- establishment of origin. zilian Animal Products Inspection System. Art. 31. Pigs in interstate transit for fattening purposes shall be accompanied with the tran- where an Eradication Plan is being implemented, sit document and the certificate issued by the Of- the vehicle should be ordered to return to its place ficial Veterinary Service attesting that the animals of origin - except for animals affected by the dis- originate in a rearing establishment where there ease - and the appropriate legal sanctions applied. has been no AD outbreaks in the past twelve (12) Paragraph 2. Where irregular transit is inter- months, except in the case of those Units of the cepted in the interior of the Federative Unit where Federation recognized as free of AD by the Minis- an Eradication Plan is being implemented, the ve- try of Agriculture, Livestock and Food Supply, as hicle should be seized, the animals sacrificed, and the Central and Higher-level Authority. the appropriate legal sanctions applied. Sole Paragraph. The entry of pigs originat- Paragraph 3. In the case of products and by- ing in other Federative Units for the purpose of products of swine origin, these should be seized immediate slaughter regardless of their sanitary and destroyed or otherwise disposed of at the condition for AD is hereby permitted, provided discretion of the competent authority, and the that in compliance with the legislation in force. appropriate legal sanctions applied. Art. 32. The transit of pigs between zones in the same sanitary conditions for AD through zones in inferior sanitary conditions should take CHAPTER IX place in a vehicle sealed by the Official Veterinary Service of the Federative Unit of origin. GENERAL PROVISIONS Sole Paragraph. No one other than a member of the Official Veterinary Service should break Art. 35. Where AD is detected in slaughter- the seal at the place of destination. houses, exhibits, auctions and other areas of pig Art. 33. The interstate transit of products concentration, the whole area shall be consid- and byproducts of pigs that have been submit- ered a outbreak and the sanitary measures pro- ted to sanitary slaughter due to an AD outbreak vided for herein and in the AD Contingency Plan is hereby prohibited. shall apply, as appropriate. Art. 34. Where the non-fulfillment of the Art. 36. The measures provided for herein rules approved for the transit of pig and products should be implemented with due regard for the and byproducts thereof is detected, the compe- other recommendations contained in the AD tent authorities at the Intermediate Level will be Contingency Plan. 304 responsible for impeding the transit and register- Art. 37. Other situations not mentioned ing the fact, pursuant to the applicable law. herein shall be addressed by the Ministry of Ag- Paragraph 1. Where irregular transit is inter- riculture, Livestock and Food Supply, as the Cen- cepted within the borders of the Federative Unit tral- and Higher-level Authority.

ANNEX II

CONTINGENCY PLAN

I - INTRODUCTION operation of Jezuíno Maciel, that the “Scratching 1. Background Pest” was found to be nothing more than Aujesz- In 1908, Carini had the opportunity to work ky’s Disease (AD). The finding was confirmed dur- with material derived from cattle and dogs in- ing an AD outbreak in the municipality of Araras, fected with the so-called “Scratching Pest”. Out- in the State of São Paulo. breaks of the disease, then of obscure etiology In 1934, Decree No. 24,548 defined AD as and detected in several Brazilian states, were a disease of mandatory notification in Brazil rather frequent. It was only in 1912, with the co- and subject to animal sanitary health and inspection measures. In 1939, Carneiro & Leme animal sanitary health and inspection measures diagnosed AD in sheep and goat. In the same required to control and eradicate the disease year, Carneiro detected the disease in pigs by throughout the national territory. performing the viral Neutralization Test during II - EPIDEMIOLOGICAL CHARACTERIZATION a DA outbreak in bovine. The ADV was first iso- 1. Minimum sanitary conditions lated in Brazil in 1947. The zoosanitary management strategy should Since 2001, the State of Santa Catarina has outbreak on the design and adoption of measures implemented a program to eradicate AD in that minimize the risk of introduction or reintro- swine, with the participation of EMBRAPA Swine duction of a disease in a free country or zone. and Birds, the Intermediate Stage of the System Effective activities of different natures are of Attention to Agriculture and Livestock Health required to minimize the risk of DA outbreaks in the state (CIDASC), the public accredited labo- and ensure the immediate detection and adop- ratory (CEDISA), the Association of Swine Breed- tion of the measures required to control and ers in the state (ACCS), agroindustries and the eradicate any possible outbreak. The Official support of the Ministry of Agriculture, Livestock Veterinary Service should be underpinned in the and Food Supply and the State Agriculture and following conditions: Rural Development Secretariat. - An appropriate operational framework; 2. Justification - Legal support for the actions, provided for In the past decades, swine culture in Bra- in specific legislation; zil went through intensive technification with - Sufficient and readily available financial respect to management practices by increasing resources; confined production and the movement of ani- - Sufficient and appropriate human and ma- mals. These factors enhance the risk of disease terial resources and equipment; outbreaks and dissemination amongst the coun- - A permanently updated register of swine try’s swine herd. Regardless of how strict the pro- breeders and transporters; tection sanitary measures taken by a country, a - Staff trained in sanitary emergency; region or a zone free of a disease might be, there - A sanitary Education Program that takes is no absolute guarantee that the infectious into account the habits of each region; agent will not be introduced or reintroduced. - Active surveillance in commercial and sub- When there is an outbreak in a herd, the sistence swine exploitation activities; 305 actions to control or eradicate it should be car- - Information systems that enable the quick ried out in an organized, quick and effective way, adoption of sanitary measures; with a view to minimizing the impact of result- - An updated list of risk sites such as agroin- ing losses. In this regard, it is necessary to main- dustries, slaughterhouses, landfills, pet food tain both the technical staff of the three levels of industries, agriculture and livestock shops, bus Authority that make up the Unified System of Ag- stations, airports, ports, and post offices among riculture and Livestock Health and the support- others; ing staff permanently trained and with access to - Permanent inspection and evaluation of adequate equipment and materials, sufficient animal health activities, with a view to improv- and easily available funds, as well as rules that ing and standardizing actions; enable guiding the procedures to be adopted - Active action by the State Swine Health and the necessary legal support. Committee; 3. Objective - Performance of periodic serum epidemiolog- This CONTINGENCY PLAN contributes to ical inquiries for monitoring disease free zones; guide actions and procedures towards the early - Control and inspection of pig transit, and immediate notification and confirmation products and byproducts thereof, pathological of suspected outbreaks of AUJESZKY’S DISEASE and biological products, and animal reproduc- (AD), as well as to the implementation of the tion materials; - Sanitary surveillance in ports, airports, - General Coordination Unit; frontier posts and post offices; - Field Coordination Unit; - Control and inspection of areas of pig con- - Laboratory Coordination Unit; centration; - Administrative/Financial Coordination Unit; - Diagnosis laboratories capable of perform- - Communications and Public Relations Co- ing tests with the required swiftness and efficacy; ordination Unit; - Funds for payment of compensations relat- - Legal Affairs Coordination Unit. ing to herds affected by sanitary measures and In order to ensure the efficacy of the ac- the destruction of things; tions implemented by the sanitary emergency - Systematic fight against clandestine team, the members thereof should be submit- slaughter; ted to periodic technical and operational train- - Washing and disinfection of swine trans- ing in the form of simulation of outbreaks of portation vehicles after unloading in slaughter- swine disease outbreaks. houses, with inspection of such actions in fixed 3. Responsibilities of the sanitary emer- and mobile control posts; gency team - Prohibition to raise pigs in city dumps; - To implement the animal sanitary health - Control in the use of leftovers to feed pigs; and inspection policy determined by the Contin- - Pig identification systems that enable gency Plan; traceability; - To request, where necessary, the collabora- - Interaction between animal sanitary health tion of other sectors concerned in implementing and inspection services at their different levels; the actions; - Interaction with environmental and rural - To meet on a regular basis in order to fol- extension agencies, agricultural schools, rural low up and evaluate all aspects related to field schools and agrarian science schools; operations; - Interaction with municipal agriculture and - To request, where necessary, the technical health secretariats; assistance and cooperation of national or inter- - Interaction with agroindistries, coopera- national consultancy; tives, rural unions, producers’ associations and - To appoint an epidemiologist to advise the other agribusiness sectors; Field Coordinator. - Support of agencies and entities linked to 4. Duties and responsibilities of the Co- 306 the swine production chain and other public en- ordination Units tities (City Halls, the Military Police, Finance Sec- 4.1. General Coordination Unit retariat, etc.); and a) To mobilize and coordinate the emergen- - Maintenance of a strategic stock of vaccines. cy team and necessary staff; III – SANITARY EMERGENCY b) To involve the institutions and entities 1. Definition that will participate in the works; and A sanitary emergency is the set of sanitary c) To establish the evaluation and taxation actions required to prevent the dissemination committee, comprised of a representative of the and eradicate a outbreak of the disease within Production Sector, a representative of the Cen- the shortest time possible and at the lowest cost tral- and Superior- level Authority and a repre- for the country. These actions should be carried sentative of the Intermediate-level Authority of out by a group of professionals trained in sani- the Official Veterinary Service. tary emergency. 4.2. Field Coordination Unit 2. Sanitary emergency team a) To coordinate all routine operations relat- The sanitary emergency team should be es- ed to sanitary emergencies at field level as well tablished by legal act and comprised of profession- as action strategies adopted; als from the Official Veterinary Service, distributed b) To appoint and oversee the following according to the following areas of action: committees: Epidemiological surveillance: responsible IV - OPERATION PROCEDURES IN VETERI- for the information system and activities in- NARY CARE volving tracing, inspection, repopulation, 1. Notification of suspicion quarantine, animal transit, establishment of - Every veterinarian, owner and transport- fixed and mobile posts, and control of animal er of animals, or any other citizen that gains concentration sites; knowledge of a suspected outbreak of AD or of - Sacrifice and destruction, sanitary slaugh- any other disease with a similar clinical picture ter and destruction of things; should immediately notify the closest unit of the - Cleaning and disinfection of facilities and Official Veterinary Service, pursuant to the legis- vehicles and other biosafety procedures; lation in force. - Control of vaccines and vaccinations; - The notification can be provided per- - Communication and sanitary education. sonally, by telephone, fax or any other avail- Note: The heads of these committees will be able media. in charge of leading and executing the actions 2. Attention to the notification related to their tasks, so as to achieve the specific - Where the person providing the notifica- objectives thereof. tion is the owner or person in charge, he/she c) To ensure logistic support for the com- should be informed of the prohibition to remove mittees; pig and other animals as well as products and d) To demarcate protection and surveil- byproducts thereof from the farm, until the Offi- lance areas; cial Veterinary Service has defined the measures e) To make contact with authorities and other to be taken; local segments that could provide assistance; and - To record the fact, including date and time, f) To ensure that all field reports are pre- in the Local Unit of Care to Agriculture and Live- pared and submitted to the General Coordina- stock Health; tion Unit in a timely manner. - To gather as much information as pos- 4.3. Laboratory Coordination Unit sible on the rearing establishment under sus- a) To work with the Field Coordination picion, such as geographic location, natural Unit so as to ensure that samples are properly barriers, access routes, registration data, type collected, processed, identified, packed and of rearing establishment, neighboring estab- dispatched. lishments, existing pig population, entry and 307 4.4. Administrative and Financial Coordi- exit of animals in the past 30 days, production nation Unit data, previously notified diseases, slaughter- a) To work with the General Coordination houses and establishments selling products Unit with a view to preparing budgets and pro- and byproducts of swine origin; curing, distributing and ensuring the supply of - To inform immediate management; materials and services; - To have the materials and equipment re- b) To coordinate and manage the evaluation quired for handling a outbreak as specified in and taxation committee. this Contingency Plan as well as the following 4.5. Communications and Public Relations documents: Initial Disease Investigation Form Coordination Unit (FORM-IN), Term of Visit to a Swine Farm (Annex a) To work with the General and Field Co- IV of Service Instruction DDA No. 12A, of 2002, ordination Units by collecting information and and Interdiction Notice. making sure that this reaches the media and 3. Visit to the rearing establishment suspect- competent authorities in a properly manner. ed of being infected with Aujeszky’s Disease 4.6 Legal Affairs Coordination Unit a) To organize the visit on a priority charac- a) To advise the General and Field Coordina- ter no later than 12 hours after notification and tion Units on legal matters and handle all legal follow the procedures below: processes inherent in sanitary emergencies. - First of all, visit the rearing establishment suspected of AD by going straight to the main . Place the samples in isothermal boxes house, office or management, in order to collect containing dry or recyclable ice and send them information from the owner or person in charge. immediately to the laboratory. If it is not pos- Avoid driving an official vehicle into the property; sible to have the material arrive at the Labora- - Change clothes, wearing preferably dispos- tory within 24 hours after collection, this should able clothes and using disposable materials when be frozen, except for the material preserved in entering the premises where the animals are kept; formaldehyde; - Start by performing a clinical examination - For the serological diagnosis, collect blood in apparently healthy animals; samples of sick pig, sows that have had recent - Perform the clinical examination in sick ani- miscarriages or other reproduction problems, mals with the assistance of official or private staff; and those sows whose piglets display clinical - Where the suspicion is confirmed, fill out signs of AD; the FORM-IN and the Interdiction Notice; - If possible, the blood should be turned into - Where the suspicion is not confirmed, fill serum still at the rearing establishment. Serum out the Term of Visit to a Swine Farm or a similar samples should be clear, free of hemolysis, at a form available from the Intermediate-level Au- minimum of 2ml per animal. The serum should thority; be frozen and sent to the official or accredited - Prescribe spraying of the facilities with a laboratory; solution of one of the disinfectants described in - Each and every collection of suspicious ma- this Contingency Plan, once a day, as a way to terial must be accompanied with the FORM-IN; reduce the pressure of infection in the rearing - Arrange for the destruction of the carcasses establishment; of sacrificed pigs for sample collecting purposes, - Collect samples and immediately notify by incineration or cremation followed by burial; the superior sanitary authority, so that the emer- - Prescribe the destruction, by incineration gency actions can be started forthwith; or cremation followed by burial, of all animals - Send the material collected to the closest killed in the rearing establishment as well as re- official or accredited laboratory, with a view to mains of deliveries and miscarriages. Never al- obtaining an AD diagnosis. low these materials to be fed to other animals IMPORTANT: The destination laboratory such as dogs and cats; should be previously informed that the suspi- - When leaving the suspected establishment, 308 cious material is being sent. clean up and disinfect the equipment and mate- b) To collect the Material rials used in clinical examinations and sample - Sacrifce sick animals and collect samples of collections, doing the same to the vehicle; tissues, preferably brain, spleen, tonsils and lungs; - Incinerate all disposable working clothes. - A miscarried fetus could be collected, pro- When clothes and other materials cannot be vided that accompanied with other materials, so cleaned and disinfected still at the rearing es- as not to mask the diagnosis in case the miscar- tablishment, put them in plastic bags and make riage is secondary to the infection by ADV; sure they are washed and disinfected as soon as - The materials should be sent to the labora- possible; tory in the following conditions: - As a precaution, all personnel in the of- . Send at least 50 grams of each organ in sepa- ficial service and other people who had contact rate collection vials properly identified by animal; with the suspected herd, as well as employees of . Send also fine fragments of brain and lungs the rearing establishment, should not be in con- preserved in a formaldehyde solution at 10%; tact with other pig for the following forty eight . All samples collected should be listed in (48) hours; the FORM-IN and carefully identified with a label - Where the laboratory result is negative for or adhesive tape written in pencil, and protected AUJESZKY’S DISEASE, interdiction of the establish- with transparent tape; ment should be suspended, but the epidemiological surveillance should continue for 21 days. The d) Review of the demarcated affected zone, samples will be used for a differential diagnosis, with possible expansion thereof, according to which will determine the measures to be taken. the information collected during complemen- V - PROCEDURES TO BE ADOPTED DURING tary investigations; A SANITARY EMERGENCY e) Placement of interdiction signs in strate- Where the laboratory diagnosis is positive gic locations; for AD, the emergency team should be called in f) Inspection of rearing establishments and so the Contingency Plan can be implemented swine slaughterhouses located in the demarcat- and the necessary legal measures taken. ed zone; and 1. Demarcation of the action zone g) Composition of the committees in charge Once the primary outbreak has been deter- of emergency actions. mined, this should be georeferenced according 2. Strategies to be adopted in the out- to the Geodesic Geographic Coordinate System, break and direct contacts thereof using the Global Position System (GPS) set at Taking into account factors such as size, de- the Datum Horizontal “South America Datum gree of herd segregation, estimated number of 1969 - SAD69”, so as to demarcate the protection AD-infected animals, and the risk of dissemination and surveillance zone that will be comprised to other establishments, as well as in view of the by the area adjacent to the outbreak, within a results of the serum epidemiological investigation minimum radius of five (5) kilometers from the performed, or in accordance with the provisions outbreak, taking into account geographic and of the State Plan to Eradicate AD approved by the epidemiological factors. Ministry of Agriculture, Livestock and Food Supply, Depending on the density of the pig popula- rearing establishments associated with the sanitary tion, geographic barriers or any factor that favors emergency may be submitted to one or more of or hinders ADV dissemination, the size of the pro- the action strategies described in this chapter. tection and surveillance zone can be altered, at Rearing establishments submitted to any the discretion of the Official Veterinary Service. of the eradication strategies should have their The General Coordination Unit will request status of free of DA confirmed by obtaining two the cooperation of public entities and agencies consecutive negative serologies at two- month (the military police, city halls and others), with intervals and performed independently for the a view to isolating the outbreak, strengthening rearing stock and fattening animals, pursuant to 309 preventive sanitary measures and guaranteeing the sampling shown on the table below. The first implementation of the Contingency Plan. serology should be performed right after parturi- Where an AD outbreak is confirmed in ex- tion of the first batch of sows introduced. hibit, fair or auction facilities or other sites of pig concentration, the whole area should be consid- HERD SAMPLED ered a outbreak and be subject, as appropriate, ANIMALS to the sanitary measures provided for in this Contingency Plan. 1 – 25 ALL The Field Coordination Unit will immedi- 26 – 30 26 ately determine the following actions: 31 – 40 31 a) Establishment of the main office headquarters; 41 – 50 35 b) Establishment of the following areas of 51 – 70 40 action: 71 – 100 45 - Outbreak 101 – 200 51 - Protection and surveillance zones 201 – 1200 57 c) Establishment of fixed and mobile inspection posts in the demarcated zone; + 1200 59 2.1 Immediate depopulation the owner of the animals to be destroyed, with In this sanitation strategy, the rearing the necessary details to prevent the work from establishment(s) involved will go through im- being delayed; mediate sanitation procedures, with the sacrifice - The sacrifice can be carried out by mem- and sanitary slaughter of the whole pig herd, bers of the public security forces, with subse- regardless of the age and physiological state of quent destruction by incineration or cremation the females in the herd, and will be repopulated followed by burial. Burial is, in general, the most with pigs free of ADV. suitable and practical method; This strategy is more expensive in the short - The pigs should be sacrificed preferably in- term, as it requires compatible funds for the pay- side the trenches and will have their abdominal ment of compensations, in addition to involving cavities open; a large apparatus. However, it minimizes compli- - Any unnecessary movement of the animals cations inherent in a longer term strategy. should be avoided and care should be taken to 2.1.1 Evaluation of animals, products and prevent them from escaping when being con- materials ducted to the trenches; Exposed pigs, as well as contaminated prod- e) Destruction of sacrificed animals: ucts, byproducts and materials should be evalu- The place for the destruction of sacrificed ated before the sacrifice or sanitary slaughter. animals should be carefully selected, according The form of animal evaluation for further to the directions of the environmental protec- compensation will be regulated by the State Plan tion agency. Factors such as soil condition, prox- or, in the absence thereof, according to the regu- imity to the outbreak, water-bearing stratum, lation in force and will be performed by the cor- safety of facilities, dominant winds and isolation responding committee and the values recorded of the area to avoid public presence should be in the Term of Evaluation, which will contain all taken into account. the criteria used (race, age, gender, identification f) Cremation and weight among others). - A shallow trench, no deeper than one meter, Any dispute with respect to the values as- should be excavated. A layer of firewood or thick signed will not prevent the sanitary action from wood should be placed diagonally in the trench, going forward. which should be filled with straw, thin wood or 2.1.2 Sacrifice and destruction charcoal soaked in kerosene or diesel oil; 310 a) AD infected pig, direct contacts thereof, - The dead animals should be lined up on waste, as well as those piglets that have not this layer of firewood, alternating head and tail. reached the appropriate weight for sanitary Additional wood or charcoal soaked in diesel or slaughter will be submitted to sacrifice and de- kerosene should be placed over and around the struction at the rearing establishment, or any dead animals. Use a torch launched from a safe other adequate location at the discretion of the distance or a trail of gunpowder to light the fire; Field Coordinator, after an evaluation and within - Estimates show that cremating 250 adult no more than twenty four (24) hours after receipt pigs requires around 6 tons of charcoal, ½ a of the killing order issued by the Sacrifice and ton of wood, 75 liters of diesel and 45 kilos of Destruction Committee; thin wood; b) In the case of sacrifice and destruction of g) Cremation should be followed by burial; pig, the provisions of specific legislations should the whole process should be monitored by an of- be complied with; ficial employee; c) These tasks are performed by the Sacrifice - The trenches should be built preferably in and Destruction Committee under the supervi- the dominant direction of the winds, and be 2.5 sion of an official veterinarian; meters deep and 2.5 meters wide. The length will d) Operationalization: depend on the number of animals – 1.5 meter - Written notification should be sent to per each 5 adult pigs. Dead animals should be laid down side by side, alternating head and tail; should start immediately, followed by the re- - The ramp down the trench should be moval of waste from collecting tranches; smooth. Lime should not be used, as it delays b) All materials (organic matter, food left- the natural decomposition process that favors overs and others) resulting from dry cleaning inactivation of the virus; should be buried or completely destroyed by - Once the trenches have been covered, it is incineration; recommended that the area be surrounded with c) Proceed to the first wet cleaning, using a wire mesh, so as to prevent small animals from water under pressure pipe systems: excavating the site; - Use a high-pressure jet washer (1.000 to - It is recommended that the trenches 2.000 pounds); and adjacent areas be inspected at least once - Start by washing the premises with water, a week, until the rearing establishment has preferably containing a detergent (1 to 1.5 liter been repopulated. of solution per m2), to facilitate removing the NOTE: Where the competent environmental organic matter stuck to walls and floors; agency prohibits burial in the property, other lo- -Remove, disassemble and wash the equip- cations designated by the Ministry of Agriculture, ment (food-trough, drinkers and others); Livestock and Food Supply will be used. - Wash all surfaces in the facilities (inside 2.1.3 Sanitary slaughter and outside areas, ceiling and walls); a) Healthy pigs and indirect contacts thereof - Finally, wash the waste collection trenches residing in the same rearing establishment (out- (both internally and externally). break) will be submitted to a risk assessment and d) Perform the first disinfection (24 to 48 may be sent for sacrifice and destruction or im- hours later, after the facilities have dried up mediate sanitary slaughter, at the discretion of completely): the Official Veterinary Service; - Use a motorized sprayer; b) In the case of sanitary slaughter, the ani- - Use one of the disinfectants listed in this mals will be sent to swine slaughterhouses rec- Contingency Plan, diluted and prepared as recognized by the Brazilian Animal Products Inspec- ommended by the manufacturer so as to inacti- tion System; vate the virus; c) Loading of the pigs should be supervised - Clean all the surfaces of the facilities and by the Official Veterinary Service, which will seal equipment, including ceiling, walls and waste 311 the transportation vehicle and include the seal collection trenches, using 400 ml of the disin- number in the transit document; fecting solution/m2 of surface, unless otherwise d) The inspection service in the establish- recommended in the manufacturer’s directions; ment of destination should be notified at least - Keep all doors, windows and curtains 24 hours in advance, so as to take the measures closed for 48 hours; provided for in the applicable legislation; - After that, open windows and curtains so e) The disposal of products resulting from as to allow the sun to come in. sanitary slaughter will comply with the legisla- e) Second disinfection (15 to 20 days after tion in force; the first one): f) If it is impossible to have the sanitary - Use one of the disinfectants listed in this slaughter in establishments recognized by the Contingency Plan, with an active principle differ- Brazilian Animal Products Inspection System, ent from that used in the first disinfection, di- the animals will be submitted to sacrifice and luted as recommended by the manufacturer in destruction in the farm itself, under the direct order to inactivate the virus; supervision of the Official Veterinary Service. - Clean all the surfaces of the facilities and 2.1.4 Clean-up and Disinfection equipment, including ceiling, walls and waste a) As soon as a room or facility is free of collection trenches, using 400 ml of the disin- animals, dry cleaning with broom and shovel fecting solution/m2 of surface, unless otherwise recommended in the manufacturer’s directions; form an assessment of the risk of reintroduction - Keep all doors, windows and curtains of ADV in each area to be repopulated; closed for 48 hours; b) The rearing establishment should be - After that, open windows and curtains so repopulated only with animals originating in as to allow the sun to come in. ASBF; f) Two days after the second disinfection, it c) Fattening establishments should be re- is recommended that the producer paint the fa- populated with animals originating in rearing cilities with hydrated virgin lime; establishments that have tested negative for AD; g) As the facilities are occupied over time, d) Actions to improve the biosecurity of the one day before lodging the swine in a room or breeding establishment should be encouraged. house, a third disinfection using sodium hy- These include: isolation with perimeter fence or pochlorite-based disinfectant is recommended. vegetal cord and construction of carrier for pigs 2.1.5 Downtime far from the facilities, among others. a) The minimum period a rearing establish- 2.2 Gradual depopulation ment should be empty (void of any pig) is thirty In the AD eradication methodology by (30) days; gradual depopulation of a rearing establishment b) As soon as the rearing establishment has identified as an outbreak, the swine herd should been depopulated and during the downtime pe- be submitted to sanitary slaughter no later than riod, some actions must be taken: ninety (90) days from the initial diagnosis. - Empty laystalls; This strategy is less expensive, but requires - Implement a systematic plan to eliminate great power of organization and interaction on rodents; the part of the official service and other seg- - Eliminate leftovers of inputs and animal ments involved in enforcing eradication mea- food; sures. It may be adopted, depending on the State - Clean the area around the premises, re- Plan, in the following situations: moving garbage and debris; - In sucking pig production units or full-cy- - Clean and maintain the animal food factory. cle production establishments, where the preva- c) As provided for in the State Plan to Eradi- lence of ADV is high; cate AD, the Federative Units may consider the - In continuous cycle pig fattening units with introduction of sentinel pigs in the rearing es- any prevalence of ADV infection, where the “all 312 tablishment once the downtime period is over. in/all out” system is not used; These sentinels will be monitored so as to prove - In regions with low pig density where AD the absence of viral activity in the environment. has been detected, even with a low ADV preva- The sentinels should originate in ASBF (Granja de lence in the herds; Reprodutores Suídeos Certificada) or in another - In the outbreak of the clinical disease. establishment that has tested negative for AD, by 2.2.1 Evaluation of animals, products and obtaining two consecutive negative serologies at materials an interval of 14 to 21 days between them. The Exposed pig, as well as contaminated prod- number should correspond to 5% of the popula- ucts, byproducts and materials should be evalu- tion that existed in the outbreak or a minimum ated before sacrifice and destruction or sanitary of five sensitive pigs no more than 60 days old. slaughter. These animals should be distributed in such a The form of animal evaluation for subse- way so as to cover all premises in the rearing es- quent compensation will be regulated by the tablishment. State Plan or, in the absence thereof, by the 2.1.6 Repopulation regulation in force, and will be performed by a) Repopulation will only be authorized af- the corresponding committee and the values ter the rearing establishment has been inspected recorded in the Term of Evaluation, which will by the Official Veterinary Service, which will per- contain all the criteria used (race, age, gender, identification and weight among others). being conducted to the trenches; Any dispute with respect to the values as- e) Destruction of sacrificed animals: signed will not prevent the sanitary action from The place for the destruction of sacrificed going forward. animals should be carefully selected, according 2.2.2 Vaccination of the herd to the directions of the environmental protec- a) There should be a mass vaccination of tion agency. Factors such as soil condition, prox- herd above seven years of age, until the com- imity to the outbreak, water-bearing stratum, plete depopulation of the rearing establish- safety of facilities, dominant winds and isolation ment, so as to prevent dissemination of the of the area to avoid public presence should be clinical disease; taken into account. b) Where the rearing establishment adopts f) Cremation vaccination against AD, piglets born from vacci- - A shallow trench, no deeper than one meter, nated mothers should not be vaccinated; should be excavated. A layer of firewood or thick c) Vaccination procedures should comply wood should be placed diagonally in the trench, with the legislation in force. which should be filled with straw, thin wood or 2.2.3. Sacrifice and destruction charcoal soaked in kerosene or diesel oil; a) AD-infected pig, direct contacts and waste - The dead animals should be lined up on thereof, as well as those piglets that have not this layer of firewood, alternating head and reached the appropriate weight for sanitary tail. Additional wood or charcoal soaked in slaughter will be submitted to sacrifice and de- diesel or kerosene should be placed over and struction at the rearing establishment, or any around the dead animals. Use a torch launched other adequate location at the discretion of the from a safe distance or a trail of gunpowder to Field Coordinator, after an evaluation and within light the fire; no more than twenty four (24) hours after receipt - Estimates show that cremating 250 adult of the killing order issued by the Sacrifice and pigs requires around 6 tons of charcoal, ½ a Destruction Committee; ton of wood, 75 liters of diesel and 45 kilos of b) In the case of sacrifice and destruction of thin wood; pig, the provisions of specific legislations should g) Cremation should be followed by burial; be complied with; the whole process should be monitored by an of- c) These tasks will be performed by the Sac- ficial employee; 313 rifice and Destruction Committee under the su- - The trenches should be built preferably in pervision of an official veterinarian; the dominant direction of the winds, and be 2.5 d) Operationalization: meters deep and 2.5 meters wide. The length will - Written notification should be sent to the depend on the number of animals – 1.5 meter owner of the animals to be destroyed, with the per each 5 adult pigs. Dead animals should be necessary details to prevent the work from be- laid down side by side, alternating head and tail; ing delayed; - The ramp down the trench should be - The killing can be carried out by members smooth. Lime should not be used, as it delays of the public security forces, with subsequent de- the natural decomposition process that favors struction by incineration or cremation followed inactivation of the virus; by burial. Burial is, in general, the most suitable - Once the trenches have been covered, it is and practical method; recommended that the area be surrounded with - The pigs should be sacrificed preferably in- a wire mesh, so as to prevent small animals from side the trenches and will have their abdominal excavating the site; cavities open; - It is recommended that the trenches - Any unnecessary movement of the ani- and adjacent areas be inspected at least once mals should be avoided and care should be a week, until the rearing establishment has taken to prevent them from escaping when been repopulated. NOTE: Where the competent environmental animals, dry cleaning with broom and shovel agency prohibits burial in the property, other lo- should start immediately, followed by the re- cations designated by the Ministry of Agriculture, moval of waste from collecting tranches; Livestock and Food Supply will be used. b) All materials (organic matter, food left- 2.2.4 Sanitary slaughter overs and others) resulting from dry cleaning a) The following principles should be com- should be buried or completely destroyed by plied with in the sanitary slaughter of the herd incineration; in establishments recognized by the Brazilian c) Proceed to the first wet cleaning, using Animal Products Inspection System: water under pressure pipe systems: - Immediate sanitary slaughter of non-preg- - Use a high-pressure jet washer (1.000 to nant sows up to the 60th day of pregnancy and 2.000 pounds); replacement sows; - Start by washing the premises with water, - Immediate castration of boars, which preferably containing a detergent (1 to 1.5 liter should be sent for sanitary slaughtering when of solution per m2), to facilitate removing the in good conditions, pursuant to the legislation organic matter stuck to walls and floors; in force; -Remove, disassemble and wash the equip- - Lactating sow should wait until the wean- ment (food-trough, drinkers and others); ing period is over and then be sent for sanitary - Wash all surfaces in the facilities (inside slaughtering when in good conditions, pursuant and outside areas, ceiling and walls); to the legislation in force; - Finally, wash the waste collection trenches - Sow sixty (60) days pregnant or more should (both internally and externally). wait for delivery, in which case the provisions of d) Perform the first disinfection (24 to 48 the previous item will apply; hours later, after the facilities have dried up - Piglets in nursery or crèche should be sent completely): for sanitary slaughter at approximately twenty - Use a motorized sprayer; three (23) kilos of live weight; - Use one of the disinfectants listed in this - Piglets in the fattening stage should be Contingency Plan, diluted and prepared as rec- sent for sanitary slaughter when they reach the ommended by the manufacturer so as to inacti- optimal weight. vate the virus; b) The loading of pigs should be followed - Clean of the surfaces of the facilities and 314 by the Official Veterinary Service, which will seal equipment, including ceiling, walls and waste the transportation vehicle and include the seal collection trenches, using 400 ml of the disin- number in the transit document; fecting solution/m2 of surface, unless otherwise c) The inspection service in the establish- recommended in the manufacturer’s directions; ment of destination should be notified at least - Keep all doors, windows and curtains 24 hours in advance, so as to take the measures closed for 48 hours; provided for in the applicable legislation; - After that, open windows and curtains so d) The disposal of products resulting from as to allow the sun to come in. sanitary slaughter will comply with the legisla- e) Second disinfection (15 to 20 days after tion in force; the first one): e) If it is impossible to have the sanitary - Use one of the disinfectants listed in this slaughter in establishments recognized by the Contingency Plan, with an active principle differ- Brazilian Animal Products Inspection System, ent from that used in the first disinfection, di- the animals will be submitted to sacrifice and luted as recommended by the manufacturer in destruction in the farm itself, under the direct order to inactivate the virus; supervision of the Official Veterinary Service. - Clean the surfaces of the premises and 2.2.5 Clean-up and disinfection equipment, including ceiling, walls and waste a) As soon as a room or facility is free of collection trenches, using 400 ml of the disinfecting solution/m2 of surface, unless otherwise by the Official Veterinary Service, which will per- recommended in the manufacturer’s directions; form an assessment of the risk of ADV reintro- - Close all doors, windows and curtains for duction in each area to be repopulated; 48 hours; b) If the risk is identified, the repopulation - After that, open windows and curtains so should be delayed, or at the discretion of the State as to enable the action of solar beams. Plan, will be made the vaccination of the animals f) Two days after the second disinfection, it destinated to the breeding establishment is recommended that the producer paint the fa- c) The rearing establishment should be cilities with hydrated virgin lime; repopulated only with animals originating in g) As the facilities are occupied over time, ASBF; one day before lodging the pigs in a room or d) Fattening establishments should be re- premises, a third disinfection using sodium hy- populated with animals originating in rearing pochlorite-based disinfectant is recommended. establishments that have tested negative for AD; 2.2.6 Downtime e) Actions to improve the biosecurity of rear- a) The minimum period a rearing establishing establishment should be encouraged. These ment should be empty (void of any pig) is thirty include: isolation with perimeter fence or veg- (30) days; etal cord and construction of carrier for pigs far b) As soon as the rearing establishment has from the facilities, among others. been depopulated and during the downtime pe- 2.3 Eradication by serology riod, some actions must be taken: In the AD eradication methodology by serol- - Empty laystalls; ogy, the rearing establishment will be submitted - Implement a systematic plan to elimi- to periodic serological tests that are capable of nate rodents; telling if the humoral titers result from the ADV - Eliminate leftovers of inputs and animal infection or from the vaccination process (if ad- food; opted), with a gradual elimination of the herds - Clean the area around the facilities, re- that tested positive for AD. moving garbage and debris; This strategy can be adopted, depending on - Clean and maintain the animal food factory. the State Plan, in those rearing establishments c) As provided for in the State Plan to Eradi- where the prevalence of ADV is low, or in those cate AD, the Federative Units may consider the establishments infected with ADV but with no 315 introduction of sentinel pig in the rearing es- manifestation of the clinical disease. This pro- tablishment once the downtime period is over. cess is quite toilsome from the standpoint of These sentinels will be monitored so as to prove vaccination management, frequent collections the absence of viral activity in the environment. of material for serology tests and laboratory ca- The sentinels should originate in Accredited pacity to produce diagnoses. Swine Breeding Farms (ASBF) or in another es- 2.3.1 Vaccination of the herd tablishment that has tested negative for AD, by a) There should be a mass vaccination of obtaining two consecutive negative serologies herd above seven years of age, until the com- at an interval of 14 to 21 days between them. plete depopulation of the rearing establish- The number should correspond to 5% of the ment, so as to prevent dissemination of the population that existed in the outbreak or a clinical disease; minimum of five susceptible pigs no more than b) Where the rearing establishment adopts 60 days old. These animals should be distrib- vaccination against AD, piglets born from vacci- uted in such a way so as to cover all premises in nated mothers should not be vaccinated; the rearing establishment. c) Vaccination procedures should comply 2.2.7 Repopulation with the legislation in force. a) Repopulation will only be authorized af- 2.3.2 Serological tests performed in the rear- ter the rearing establishment has been inspected ing stock a) Material for serology should be collected - The sacrifice can be carried out by mem- in 100% of the rearing stock, thirty (30) days after bers of the public security forces, with subse- identification of the ADV infection in the herd, quent destruction by incineration or cremation from the date of the first laboratory diagnosis; followed by burial. Burial is, in general, the most b) Animals testing positive for ADV should suitable and practical method; be isolated for immediate sacrifice and destruc- - The pigs should be killed preferably inside tion, as already described; the trenches and will have their abdominal cavi- c) The tests should be repeated in 100% of ties open; the stock, with 60-day intervals using the same - Any unnecessary movement of the animals procedure, until two consecutive negative sero- should be avoided and care should be taken to logical results are obtained; prevent them from escaping when being con- d) In the second collection of material for ducted to the trenches; testing the stock, a collection by sampling of the e) Destruction of sacrificed animals: fattening herd (where it exists) should also be The place for the destruction of sacrificed performed and yield negative results, according animals should be carefully selected, according to the table contained in this Contingency Plan. to the directions of the environmental protec- 2.3.3 Evaluation of the animals tion agency. Factors such as soil condition, prox- Animals destined for sacrifice or sanitary imity to the outbreak, water-bearing stratum, slaughter should be evaluated beforehand. safety of facilities, dominant winds and isolation The form of animal evaluation for subse- of the area to avoid public presence should be quent compensation will be regulated by the taken into account. State Plan or, in the absence thereof, by the regu- f) Cremation lation in force and will be performed by the cor- - A shallow trench, no deeper than one meter, responding committee, and the values recorded should be excavated. A layer of firewood or thick in the Term of Evaluation, which will contain all wood should be placed diagonally in the trench, the criteria used (age, gender, weight, physiologi- which should be filled with straw, thin wood or cal status and loss of profits among others). charcoal soaked in kerosene or diesel oil; 2.3.4 Sacrifice and Destruction - The dead animals should be lined up on a) AD-infected pig, direct contacts and waste this layer of firewood, alternating head and tail. thereof, as well as those piglets that have not Additional wood or charcoal soaked in diesel 316 reached the appropriate weight for sanitary slaugh- or kerosene should be places over and around ter will be submitted to sacrifice and destruction at the dead animals. Use a torch launched from the rearing establishment, or any other adequate a safe distance or a trail of gunpowder to light location at the discretion of the Field Coordinator, the fire; after an evaluation and within no more than twen- - Estimates show that cremating 250 adult ty four (24) hours after receipt of the killing order is- swine requires around 6 tons of charcoal, ½ a sued by the Sacrifice and Destruction Committee; ton of wood, 75 liters of diesel and 45 kilos of b) In the case of sacrifice and destruction of thin wood; pigs, the provisions of specific legislations should g) Cremation should be followed by burial; be complied with; the whole process should be monitored by an of- c) These tasks are performed by the Sacrifice ficial employee; and Destruction Committee under the supervi- - The trenches should be built preferably sion of an official veterinarian; in the dominant direction of the winds, and d) Operationalization: be 2.5 meters deep and 2.5 meters wide. The - Written notification should be sent to length will depend on the number of animals the owner of the animals to be destroyed, with – 1.5 meter per each 5 adult pigs. Dead ani- the necessary details to prevent the work from mals should be laid down side by side, alter- being delayed; nating head and tail; - The ramp down the trench should be based on the identification of exposed herds, so smooth. Lime should not be used, as it delays as to prevent AD from disseminating. the natural decomposition process that favors The transit of pigs should be assessed as a inactivation of the virus; potential factor of disease dissemination. De- - Once the trenches have been covered, it is pending on what is found in the transit assess- recommended that the area be surrounded with ment, tracing might require the intervention of a wire mesh, so as to prevent small animals from a large number of people, under careful and sys- excavating the site; tematic coordination. - It is recommended that the trenches and Sanitary emergency activities should be car- adjacent areas be inspected at least once a ried out by specific teams in each zone of action week, until the rearing establishment has been (outbreak and direct contacts, protection and repopulated. surveillance zone, and in other areas when the 2.3.5 Sanitary slaughter investigation so recommends). Tracing in areas a) All pig identified as asymptomatic carri- outside the protection and surveillance zone will ers of ADV during the serological tests should be be the responsibility of the corresponding Local- isolated and sent for sanitary slaughter; level Authorities. b) ADV-infected animals which, according to Veterinarians and independent profes- the legislation in force are not qualified to be im- sionals linked to the field performing their mediately sent for sanitary slaughter should be activities in the infected zone, should be in- submitted to sacrifice and destruction, according formed of the presence of the disease and pro- to the provisions of item 2.3.4; vide the Official Veterinary Service with a list c) Loading of the pigs should be supervised of all the rearing establishments visited in the by the Official Veterinary Service, which will seal past seven days. the transportation vehicle and include the seal All pig slaughterhouses located in the action number in the transit document; zone and those that had some sort of relation d) Sanitary slaughter should take place in with the outbreak and direct contacts thereof, swine slaughterhouses recognized by the Brazil- could also be the object of serological investiga- ian Animal Products Inspection System; tion by the Official Veterinary Service. e) The inspection service in the establish- 3.1 Measures to be adopted in the outbreak ment of destination should be notified at least and direct contacts thereof 317 24 hours in advance, so as to take the measures a) Tracing provided for in the applicable legislation; A complete investigation of the transit of f) The disposal of products resulting from animals, persons, vehicles, equipment, food sanitary slaughter will comply with the legisla- leftovers, excrements, animal food and other tion in force; inputs destined to the rearing establishment g) If it is impossible to have the sanitary identified as a outbreak and originating therein slaughter in establishments recognized by the at least thirty (30) days before the beginning of Brazilian Animal Products Inspection System, the clinical manifestation of AD or of the labo- the animals will be submitted to sacrifice and ratory diagnosis, should be traced, for the pur- destruction in the farm itself, under the direct pose of identifying the origin of the outbreak supervision of the Official Veterinary Service. as well as its possible dissemination to other 3. Epidemiological investigation rearing establishments. Tracing at field level and an analysis of Rearing establishments receiving pigs the transit of live pig and products that are originating in the outbreak should be consid- potential carriers of ADV, should be performed ered as suspicious and be subject to the same together with the actions carried out in the out- measures taken in the outbreak. Details such break and direct contacts thereof, with the ob- as date, type of vehicle, route, destination and jective of producing a diagnosis of the situation exact location should be determined, so as to ensure the quick identification of exposed rear- ply as a Central- and Higher-Level Authority. ing establishments. 3.2 Measures to be taken in the protection Past activities of all those who worked or vis- and surveillance zone ited the rearing establishment during this period a) Population census should be assessed, as well as their relation with The Official Veterinary Service will carry other rearing establishments, pig concentrations out a census of the pig population existing in and slaughterhouses. all establishments located in the protection and b) Transit restrictions surveillance zone, no later than seven days after Interdiction of the outbreak and direct establishment thereof. contacts thereof shall remain in force until the To this end, the tracing team should visit all eradication strategy used has been completed, properties located within the established radius with the exception of the transit of pigs for im- and perform an epidemiological assessment mediate sanitary slaughter, originating in rear- by applying an Epidemiological Investigation ing establishments where there are no clinical Questionnaire, which is contained in this Con- signs in the herd. tingency Plan, with a view to determining cur- Where the rearing establishment is incapa- rent population data, the type of swine explora- ble of holding sufficient stock, it may be autho- tion activities in the rearing establishments and rized, at the discretion of the Official Veterinary any links with the outbreak establishment and Service, to transfer piglets for fattening in anoth- direct contacts thereof. er establishment, provided that it is located in b) Serum epidemiological inquiry the same Federative Unit, where the pigs will be All pig rearing establishments located in the under supervision until they reach the optimum interior of the protection and surveillance zone weight for slaughter. should be submitted to a serum epidemiological The transit of animal reproduction mate- survey based on the collection of blood from the rial (semen) should also be prohibited. Vehicles rearing stock and the herd in termination stage, transporting pigs for sanitary slaughter should in an independent manner, using the table con- not be used to transport animal food or inputs tained in this Contingency Plan. or replacement animals. In the sample from the breeding stock, it is c) Serological investigation recommended that material be collected from In those rearing establishments that received 100% of existing boars . In the case of females, the 318 pigs from the outbreak as well as in those that pro- sample should be proportional to their physiologi- vided animals to the outbreak (except ASBF), blood cal status, based on the following parameters: 70% from the herd should be collected, so that the of the samples from pregnant sows, 20% from lac- sanitary situation can be known, using the table tating sows, 5% from non-copulated replacement contained in this Contingency Plan, with a view to sows. In the case of herd in termination stage, sam- providing guidance on the choice of the best eradi- ples should be collected in all stall lodging pigs. cation strategy. In rearing establishments that re- Instructions for collecting blood: ceived pigs from the outbreak, this sample should Collect a minimum of 7 ml of blood by be guided, so that samples from animals originat- puncturing the inferior cava vein or jugular vein ing in the outbreak can be obtained. of each animal to be sampled, using clean and d) Vaccination sterile vials and needles. Use a set (a needle and Depending on the State Plan, the immediate a vial) for each sample. vaccination of pigs from the outbreak and other Right after collection, keep the vials in an rearing establishments at risk of getting the in- inclined angle and in a fresh place, until retrac- fection could be recommended, according to the tion of the clot. Centrifuge the vials at a minimum vaccination protocol contained in this Contin- speed of 2,000 rpm for five minutes. The serum gency Plan or in the State Plan approved by the obtained (at least 2 ml) should not show evident Ministry of Agriculture, Livestock and Food Sup- sings of hemolysis and should then be transferred to individual sterilized glass vials appropriately posts should include representatives of the Of- numbered and identified and be immediately ficial Veterinary Service and of the public secu- frozen. Fill out the dispatching forms and pack rity forces, equipped with permanent means of the material in isothermal boxes with dry or recy- communication with each other and with the clable ice. Keep the serum frozen throughout the Field Coordination, so as to ensure fulfillment process, until it arrives at the laboratory. of the sanitary measures adopted. Case reports c) Control of pig transit should be prepared and submitted to the Field In the protection and surveillance zone, the Coordination Unit. interdiction period of any rearing establishment Only the transit of clean and disinfected will be of at least twenty one (21) days after com- vehicles and equipment will be permitted, pur- pletion of the sacrifice and destruction of pigs in- suant to the procedures defined by the Official fected with ADV, except for the transit of animals Veterinary Service following inspection by an of- intended for slaughter, which should be made ficial employee. in sealed vehicles under control of the Official Permission to remove pigs from the protec- Veterinary Service. tion and surveillance zone may be granted in the Restriction involving the circulation and following circumstances: transportation of pigs and animal reproduc- - Directly to slaughterhouses tion material in public or private routes. This At the end of the serum epidemiological restriction may not be applied in the following investigation, the Official Veterinary Service may situations: authorize the removal of pigs directly to a swine - Transit through the protection and surveil- slaughterhouse recognized by the Brazilian Ani- lance zone by road or railway, without stops or mal Products Inspection System, preferably lo- unloading therein; cated as close as possible to the protection and - Pigs originating outside the protection surveillance zone, provided that the following and surveillance zone and intended directly to conditions are satisfied: slaughterhouses located in the same zone, as - Transportation in disinfected and sealed long as they are transported in vehicles sealed vehicles, accompanied with the Animal Move- by the Official Veterinary Service in the origin or ment Permit (GTA), with identification of the within the limits of the zone. route on the back thereof; So that transit restriction measures in the - Notification to the sanitary authority re- 319 action zone can be totally fulfilled, as many sponsible for the slaughterhouse at least twenty fixed and mobile barriers as necessary should four (24) hours in advance, so that the measures be established in strategic locations, at the dis- provided for in the legislation can be taken; cretion of the Field Coordination Unit, with a - The vehicle and equipment used to trans- view to covering every vehicle passing through port the pigs should be immediately washed and the area. disinfected, under the guidance of the official These barriers should be located within the veterinarian. perimeter of the demarcated zone and be in op- - To rearing establishments within the pro- eration no later than twelve (12) hours after the tection or surveillance zone emergency has been established. The main objec- Twenty one days after completion of the pre- tive of these posts is to ensure compliance with the liminary cleaning and disinfection operations in the measures relating to the transit of animals, animal outbreak and subject to a risk assessment, the Of- reproduction materials, vehicles and other mate- ficial Veterinary Service may authorize the removal rials that could be potential ADV carriers, such as of pigs from establishments located in the protec- animal food, excrements and effluents originating tion and surveillance zone directly to another rear- in rearing establishment or slaughterhouse located ing establishment in the same zone, provided that in the protection and surveillance zone. the following conditions are satisfied: The teams that will be working in these - Transportation in disinfected and sealed vehicles, accompanied with the Animal Move- ence of antibodies originating in the infection by ment Permit; the field virus from those induced by vaccination. - Cleaning and disinfection, after each op- The State Plan to Control and Eradicate AD eration, of the vehicles and equipment used to of each Unit of the Federation should contain transport pigs. the strategy to use the vaccine within its area d) Maintenance of measures: of action. Where the Federative Unit does not The measures applied in the protection and have a State Plan, the vaccination scheme below surveillance zone will be maintained until all should be followed: eradication strategies set out in this Contingency - Inactivated Vaccine: Plan have been competed and a serum epide- Rearing Stock: vaccinate three (3) times a miological inquiry covering all rearing estab- year. Each vaccination should be given within lishments at risk, located inside or outside the a maximum of one (1) week, regardless of the protection and surveillance zone has been per- physiological status of the females in the stock; formed and no viral activity has been detected. Sows and replacement males: give the first Depending on the State Plan, a monitoring dose of the vaccine upon arrival of the pigs and operation could be performed at slaughterhouse the second 2-4 weeks later (depending on the level, in boars intended for killing or animals in- recommendation of the product manufacturer). tended for slaughter. These vaccinations should be given during This inquiry will be carried out at least the quarantine or isolation period in the farm, thirty (30) days after completion of the killing or before the pigs are introduced into the herd. slaughter of pigs infected with ADV in the rear- IMPORTANT: Not applicable to rearing es- ing establishments affected, according to the tablishments under interdiction. sample defined on the table contained in this - Attenuated Live Vaccine (in those Federa- Contingency Plan. tive Units where its use is provided for in the VI – PROCEDURES FOR VACCINATION State Plan approved by the Ministry of Agricul- AGAINST AD ture, Livestock and Food Supply as the Central- The vaccination of pigs is an important instru- and Higher-Level Authority): ment to control the clinical manifestation of AD in Piglets: give one single dose between nine outbreaks submitted to any of the disease eradica- (9) and fourteen (14) weeks of life. tion strategies, as well as in those rearing establish- Vaccinated piglets should, under no cir- 320 ments considered at risk of getting the infection. cumstance, have a final destination other than Vaccination does not prevent the infection by slaughter. ADV, but reduces the economic impact of the dis- If the emergency action in a outbreak in- ease. Vaccination reduces and prevents the mani- cludes vaccination, give the vaccine to all pigs in festation of clinical signs by decreasing intensity of the herd over seven days of age, following the the agent and the time required to eliminate it; re- strategy used to eradicate the disease. ducing tissue invasion; increasing the viral dose re- In the case of emergency use of AD vaccine quired to infect vaccinated animals; and inducing in a free zone, this will lose its sanitary status, reduced tissue invasion (prevents transplacentary which can only be regained when the condi- transmission), in addition to reducing excretion of tions set by the federal legislation in force and the agent from infected pigs. All this ends up by by the Sanitary Code of Terrestrial Animals of the contributing to reduce the incidence of AD in rear- World Organization for Animal Health (OIE) are ing establishments that adopt vaccination. met. The rules to control the sale of AD vaccines In a pig rearing establishment, the vaccines by the Official Veterinary Service should comply should always be used by a fixed period of time, with the legislation in force. Only DA vaccines li- until the herd is considered safe, and under con- censed by the Ministry of Agriculture, Livestock trol of the Official Veterinary Service. There are se- and Food Supply as the Central- and Higher-level rological tests that enable distinguishing the pres- Authority, can be used. VII – PROCEDURES IN SLAUGHTERHOUSES DNA virus from the Herpesviridae family, Al- The sanitary slaughter of pigs involved in phaherpesvirus subfamily. sanitary emergencies will be performed exclu- Its viral envelope has glycoprotein struc- sively in slaughterhouse recognized by the Bra- tures on the surface such as the gE, which is zilian Animal Products Inspection System, and important due to its implication in the develop- the resulting products cannot be exported. ment of marked vaccines and serological diag- The inspection service in the establishment nosis techniques that enable distinguishing be- of destination should be informed at least twenty tween infected and vaccinated animals. It has four (24) hours in advance, so as to adopt the mea- one single antigenic type, although there are sures provided for in the applicable legislation. many viral strains that produce, in a predomi- The transporting vehicle should be sealed nant fashion, a respiratory or a nervous picture by the Official Veterinary Service and checked of the disease. before the animals are unloaded. An important characteristic of the agent is The sanitary slaughter of pigs resulting from its ability to remain in a latent state (subclinical a sanitary emergency should be performed ac- infection) in sensorial ganglions of the nervous cording to the legislation in force. system (trigeminus) and in the lymphoid tissue VIII – CHARACTERISTICS OF AUJESZKY’S of pig tonsils. DISEASE The latent condition of the agent makes ETIOLOGY the pig a source of viral dissemination through- 1. Characteristics of the etiological agent out its life.

2. Reaction to physical and chemical action Temperature: Nearly instant inactivation when exposed to exsiccation, mainly in the direct presence of sun beams. At 20ºC, the virus can be infectious and transmitted by flies for up to six (6) hours. In nasal discharges and saliva at 25ºC, the virus is inactivated in one (1) day on clothes and boots; four (4) days on several types of equipment and material (concrete, plastic, iron) existing in the rearing establishment; 321 three (3) days in pelleted food; two (2) days in meat flour; and four (4) days on a wood shavings bed. pH: Inactivated within seven (7) days in pH < 4.3 or pH > 9.7. Chemical Sensitive to grease solvents such as ether and chloroform. products: Disinfectants: Inactivated by disinfectants containing sodium hypochlorite, quaternary ammonia, peroxide and iodophor. Survival: Survives in cold environments but is not subject to temperature fluctuations. It is stable in pH between 6 and 8, in humid environments and stable temperature. It survives for two (2) days in anaerobic lagoons and for up to four (4) days in non-chlorinated water at 25ºC. It survives for seven (7) days in the air with humidity of 55% or higher, in humid soil and in organic matter. EPIDEMIOLOGY . Other infection ways described in item 2. 3. Hosts DIAGNOSIS The virus has a wide range of hosts, but The disease incubation period is from two pigs and boars are the only natural hosts of (2) to six (6) days. the Aujeszky’s Disease virus (ADV). Wild ani- 6. Clinical diagnosis mals could be infected and serve as a reservoir. The emergence of clinical signs depends cattle, sheep, goat, dogs, cats, equine, rats and on the age of infected pig; the degree of their mice are susceptible. In these species the dis- exposure to the etiological agent (level of herd ease is terminal, with a short incubation period segregation); the infecting viral dose; and the (3 days) and death between forty eight (48) and immunity level of the animals. seventy two (72) hours after manifestation of . Piglets in nursery (1 to 21 days old): nervous symptoms (itching with a tendency to- - Fever (41ºC), anorexia, apathy; wards self-mutilation). Reports in humans are - Tremors, ataxia, hypersalivation; not sufficiently documented. - Epiletiform convulsions, pedaling move- 4. Transmission (direct and indirect) ments, nystagmus and o e opisthotonus. . Introduction of infected pigs; - Paralysis of posterior members (sitting dog . Direct contact among animals (nasal secre- position); walk in circles; tions, saliva, faeces, blood, milk); - Vomit and diarrhea; . Vaginal and prepucial mucosa (natural - Do not respond to antibiotics therapy; copulation); - Death within 24 to 36 hours; . Semen (contamination at the time of col- - In infected females close to delivery, the lection); young are born weak, with immediate clinical . Aerogenous way (suspended aerosol, wind signs; and of at least 3 kilometers); - Mortality rate among nursing piglets close . Water, food, contaminated equipment and to 100%. bed; . Piglets in crèche (21 to 63 days old): . Transplacentary infection (congenital); - Apathy, anorexia and fever (41 - 42ºC); . Remains of deliveries and abortions/mis- - Respiratory signs: sneezes, nasal discharg- carriages; and es and dyspnea evolving to severe cough; . Dissemination by people and vehicles. - Animals with nervous signs similar to those 322 5. Virus sources of nursing piglets invariably die; Elimination of ADV starts about seven (7) to - Refusal to return to the corral; and ten (10) days after disinfection. - Recovery within five (5) to tem (10) days; . Blood and all tissues, secretions, and excre- mortality rate in general does not exceed 10%. tions of sick and dead animals; . Fattening pigs (63 days old to slaughter): . Congenitally infected piglets; - Apathy, anorexia and fever (41 - 42ºC); . Pigs suffering from reactivation of the la- - Sneezes, nasal discharges, sever cough, dif- tent state of the virus due to adverse environ- ficult breathing, mainly when the animals are mental conditions or other stress sources; forced to move; . Infected animals introduced in the rearing - Respiratory signs reach morbidity rates establishment; close to 100%; . Contaminated semen used in artificial in- - Low mortality rate (1 - 2%) in cases not ag- semination; gravated by secondary bacterial infection; . Animal food and bed in non-controlled - Sporadic nervous signs; rearing establishments; - Stunting; and . Wild swine and tayassuidae (cateto, wild - Recovery within six (6) to ten (10) days. boar, wild hog, and peccary), which are ADV res- . Breeding pigs (females and males): ervoirs; and - Anorexia and fever (as high as 42ºC); - Agalaxy; - Enzyme-linked immunosorbent assay - Constipation; (screening ELISA and differential ELISA for - Movements of false chewing and hyper- gE); and salivation; - Virus neutralization test (VN). - Reproductive signs: abortions/miscar- . Histopathology: for the differential diagno- riages, return to the oestrus cycle, still born and sis, from brain and lung samples preserved in a mummified; formaldehyde solution at 10% (formol). - Respiratory signs similar to those of fatten- In those establishments without clinical ing animals; signs, where the intention is to investigate the - Reproductive failures do not reach 20% of presence of ADV from samples of blood serum the breeding stock; collected by sampling (according to the table - Occasional nervous signs: slight lack of co- contained in this Contingency Plan), the serolog- ordination or paralysis of the posterior train; ical tests should be aimed at those sows whose - Low mortality rates (1 - 2%); and pig litters show signs consistent with AD. - Infertility. PREVENTION AND CONTROL Macroscopic injuries There is no specific treatment for Aujeszky’s Many times, macroscopic injuries are not Disease. observed. Should they occur, look particu- - Application of the measures described in larly for: the Contingency Plan in AD outbreaks; - Yellowish necrosis outbreaks in the spleen - Active serum epidemiological surveillance and liver; for the identification of rearing establishments - Hemorrhagic necrosis outbreaks in free of AD; lymphonodes and tonsils; - Eradication of the infection by complete - Pulmonary consolidation with areas dis- and immediate depopulation in regions where seminated through the different lobes; vaccination is prohibited; - Conjunctivitis; and - Mass vaccination of the herd and eradica- - Necroctic placentitis. tion of infection by gradual depopulation, with- 7. Differential diagnosis in a maximum of ninety (90) days in those herds . Swine influenza; whose serology by sampling indicates a preva- . Enzootic pneumonia; lence above 10% or in rearing establishments 323 . Swine pasterurelosis; with manifestation of the clinical disease; . Classical swine fever; - Mass vaccination of the herd and eradica- . Streptococcus meningitis; tion of soropositive animals after bimonthly test- . Neonatal hypoglicemia; ing of 100% of the rearing stock in those herds . Intoxication by salt; whose serology by sampling indicate prevalence . Leptospirosis; of the infection equal to or below 10%; . Other causes of abortion/miscarriage; and - Replacement of the breeding stock only . Other viral encephalomyelitis. with swine originating in Accredited Swine 8. Laboratory Diagnosis Breeding Farms(ASBF); . Identification of the agent: - Introduction of piglets for fattening origi- - Virus isolation from sick piglets or from or- nating in breeding establishments free of ADV; gans and tissues such as brain, spleen, tonsils, - Quarantine, with the performance of lungs, and aborted fetuses; and serological tests in animals originating in - Polymerase chain reaction (PCR), capable rearing establishments with unknown sani- of showing the presence of the viral DNA from tary status for AD; brain, spleen, tonsils, lungs, aborted fetuses or - Control of rodents; semen samples. - Treatment of products and byproducts of . Serological tests: animal origin; - Control of wild animals; and 21) Sponge; - Sanitary education. 22) Knife for necropsy; IX - EQUIPMENT AND MATERIALS FOR 23) Adhesive tape; EMERGENCY ACTIONS 24) FORM-IN and FORM-COM; Have the following equipment and materials 25) Gauze; available, preferably disposable, where possible. 26) Bow or thick rope; As a good management practice, units of these 27) Flashlight/ batteries or another source materials, organized in metallic or plastic boxes, of light; should be permanently ready: 28) Pencil and pen; 1) 100x20 or 80x15 needles; 29) Rubber or disposable gloves; 2) Pliers; 30) Map of the municipality and region; 3) 18 wire; 31) Means of identification: eartags, pliers 4) Saw arch and blade; for eartags, marking stick; 5) GPS equipment; 32) Tweezers; 6) Aprons; 33) Interdiction / direction signs; 7) Plastic buckets; 34) Drawing boards; 8) Manual or mechanical spraying pump; 35) Soap; 9) Rubber boots and shoe protector; 36) Trash bags; 10) Scalpel handle/blade; 37) Plastic bags for packing samples; 11) Pipe; 38) Syringes; 12) Box with necropsy instruments; 39) Syringe and needle; 13) Isothermal boxes and ice; 40) Term of Interdiction; 14) Impermeable pants, jacket and cap; 41) Term of Visit to a Swine Farm; 15) Cones to control the traffic of vehicles; 42) Clinical thermometers; 16) Chains/ padlocks; 43) Scissors; 17) Disinfectant with virus specification; 44) Cotton or paper towels; 18) Portable sprinkler system; 45) Vials and needles for blood 19) Brush; collection; and 20) Adhesive tape or other label for 46) Restraining blindfolds for boars. identification; 324

X – EPIDEMIOLOGICAL INVESTIGATION QUESTIONNAIRE

1. Veterinarian of the official service responsible for filling out the questionnaire: Name: Address: Telephone: E-mail: 2. Property identification: Name of property: Name of owner: General Registry No.: Tax Roll No.: Address: Municipality: Telephone: Georeferencing: coordinates: S: W: 3. Herd: Number of pigs currently existing in the property, by category: ( ) Boars ( ) Parent breeders ( ) Empty sows ( ) Lactating sows ( ) Pregnant sows less than sixty (60) days pregnant ( ) Pregnant sows more than sixty (60) days pregnant ( ) Replacement female piglets ( ) Nursing piglets ( ) Piglets in crèche ( ) Fattening piglets 4. What is the type of pig rearing? ( ) Independent ( ) Integrated or cooperative ( ) Subsistence (self-consumption only) 5. If integrated, what is the integrating company? 6. What is the type of rearing establishment? ( ) Pig farm ( ) Pig rearing ( ) Wild Boar farm ( ) Other(s). Which one(s)? 7. What is the type of exploitation? ( ) Full cycle ( ) Production of piglets ( ) Breeders or semen trade ( ) Fattening 8. What is the rearing system used? ( ) Confinement ( ) Semi-confinement ( ) Rearing technified in pickets (SISCAL) ( ) Extensive ( ) Other(s): 325 9. When was Aujeszky’s Disease identified in the rearing establishment? ( ) Month Year: ( ) It was never identified 10. Have there been clinical signs of the disease in the past twelve (12) months? ( ) Yes. Which one(s)? ( ) No 11. Has the vaccine against Aujeszky’s Disease been used or is it being used? Why? ( ) Outbreak of the disease ( ) Is located next to a farm where an outbreak has occurred ( ) Other reason(s). Which one(s)? 12. Has the origin of the infection been identified, i.e. how the disease infected the herd? ( ) Yes. What is it: ( ) No 13.How long have you been using the vaccine against Aujeszky’s Disease? ( ) Less than one (1) year ( ) One (1) to two (2) years ( ) Two (2) to four (4) years ( ) More than four (4) years ( ) Never used it ( ) Have used but stopped using it. When did you stop? Month: Year: 14. What vaccination scheme against Aujeszky’s Disease is being used? a) Sows and boars:

b) Replacement male and female piglets:

c) Piglets:

15. What is the brand and name of the vaccine being used?

16. How is the vaccine used? ( ) Irregularly ( ) Regularly ( ) Occasionally 17. If you have stopped using the vaccine, why did it happen? ( ) Technical advice ( ) Difficulty to buy ( ) High price ( ) It doesn’t work ( ) Own decision ( ) Other reason(s).Which one(s)? ( ) Solved the piglets’ mortality problem ( ) Never stopped 18. Are there any other pets in direct or indirect contact with the swine? ( ) Cats 326 ( ) Dogs ( ) Cattle ( ) Sheep and goat ( ) Free-range hens ( ) Pigeons ( ) Other(s): Which one(s)? ( ) None 19. Has there been mortality amongst any of these species when Aujeszky’s Disease was detected in the pigs? ( ) Yes. Which one(s)? ( ) No 20. What is the origin of replacement male and female piglets? ( ) The herd itself ( ) The integrating company only ( ) Neighboring farms. Which one(s)? ( ) Other suppliers of genetic material. Which one(s)?

21. Provide additional information on Aujeszky’s Disease in the farm you deem relevant:

Signature of the person responsible for the information

Stamp and signature of official veterinarian responsible for filling out the questionnaire

NORMATIVE INSTRUCTION No. 47 OF JUNE 18, 2004

Published in the Official Gazette of June 23, 2004 Section 1, Page 64 327 Approves the National Swine Health Program’s (PNSS) Technical Regulation in the form of the annex to this Normative Instruction.

THE MINISTRY OF AGRICULTURE, LIFESTOCK Art. 1. To approve the NATIONAL SWINE AND FOOD SUPPLY’S SECRETARY OF ANIMAL AND HEALTH PROGRAM’S (PNSS) TECHNICAL REGULA- PLANT HEALTH AND INSPECTION, through the TION in the form of the annex to this Normative jurisdiction conferred to it by Article 15, Sec- Instruction. tion II, Annex I, Line ‘A’ of Decree No. 4,629 of Art. 2. To delegate to the Director of the March 21, 2003, taking into consideration that Animal Health and Inspection Department the contained within the Animal Health and Inspec- power, where applicable, to add to this Regu- tion Regulation approved by Decree No. 24,548 lation. of July 3 1934 and the outcome of Process No. Art. 3. This Normative Instruction will enter 21000.012585/2003-31, resolves: in vigour on the date of its publication.

MAÇAO TADANO ANNEX

THE NATIONAL SWINE HEALTH PROGRAM’S (PNSS) TECHNICAL REGULATION

Art. 1. The present Technical Regulation ap- federal, state or municipal animal health and in- plies to the sanitary controls to be enforced in spection body. swine-rearing establishments involved in the VIII – Pig: Any animal belonging to the Sus production, reproduction,commercialisation and scrofa domesticus (domestic pig) and Sus scrofa distribution of pigs and reproduction material of (wild pig) genera. swine origin with the aim of impeding the introduction of exotic diseases and controlling or eradi- CHAPTER II cating those already existent within the country. CONCERNING RESPONSIBILITIES CHAPTER 1 Art. 3. The Animal Health and Inspection CONCERNING DEFINITIONS Depatarment (DSA) of the of Animal and Plant Health and Inspection Secretariat - part of the Art. 2. For the purposes of this Regulation, Ministry of Agriculture, Livestock and Supply terms are defined as follows: (MAPA) – is granted the following functions: I – Sanitary Slaughter: The slaughter of ani- I – To regulate, implement, control and eval- mals in establishments designated by the Official uate the execution of the National Swine Health Veterinary Service for the conditional use of car- Program’s activities in order to prevent, control casses and viscera; and eradicate diseases that affect the nation’s II – Rearing Establishment: A place where swine population; pigs are reared for whatever purpose. II – To carry out inspections and technical III – Interdiction: The prohibition of en- supervision in swine-rearing establishments; trance and exit of pig in a rearing establishment, III – To carry out supervisions and technical for whatever purpose, along with swine products audits in state and municipal Official Veterinary or byproducts or materials that may constitute a Service units. 328 medium for the transmission or propagation of IV – To control the production and quality of disease according to criteria laid out by the Of- vaccines and pharmaceutical products approved ficial Veterinary Service; by the Programme; IV – Official Veterinarian: Professional of the V – To define criteria for the adoption of di- Official Veterinary Service; agnostic techniques concerned with the importa- V – Owner: Any person, either an individual tion and utilisation of raw materials and immu- or an enterprise, in possession or control of one nobiologicals; or more pigs; VI – To propose and accompany epidemio- VI – Sacrifice and destruction : Following logical studies concerning the creation and main- confirmation of the occurrence of an emergen- tenance of disease-free zones; cy disease, a process carried out by the Official VII – To guarantee the health of pigs in all Veterinary Service consisting of the sacrifice of productive networks and the sanitary and hy- all animals pertaining to a herd that are either gienic control of the herds; sick or have come into contact with those that VIII – To propose technical training events. are and the subsequent incineration or burial of Sole paragraph. The State Agriculture Secre- their remains. This process, if necessary, will be taries or competent animal heath authorities in extended to other herds exposed, either directly the States and at the Federal District will carry or indirectly, to the pathogenic agent; out the field activities of the PNSS, subject to del- VII – Official Veterinary Service: The official egated responsibilities. CHAPTER III owner should suspend the transportation of pigs and their products and byproducts, regardless of CONCERNING PRELIMINARY CLAUSES to whom, until the Official Veterinary Service decides the measures to be adopted. Art. 4. The DSA will coordinate animal sani- Paragraph 1. All diseases designated by the tary health and inspection procedures aimed at DSA are subject to compulsory notification. the control or eradication of existing swine dis- Paragraph 2. The Official Veterinary Service will eases and also impede the introduction of exotic adopt immediately the veterinary attention and sur- diseases within the National Territory. veillance measures defined for each disease. Art. 5. The entry into National Territory of Paragraph 3. Any infraction of the rules con- pigs carrying directly or indirectly-transmissible tained within this article will be investigated by disease or either internal or external parasites, the Official Veterinary Service which, together the dissemination of which could constitute a with the Public Ministry, will pursue criminal threat to domestic swineherds, is forbidden. charges against those identified as responsible. Art. 6. The entry into National Territory of Paragraph 4. In cases where the offender is an products and byproducts derived from animals, or accredited veterinarian, as well as that contained in any other material that could act as a vehicle for paragraph 3, the Official Veterinary Service should the dissemination of swine diseases, is forbidden. proceed in accordance with specific legislation.

CHAPTER IV CHAPTER VI

CONCERNING THE REGISTRATION CONCERNING THE SANITARY INSPECTION OF SWINE-REARING ESTABLISHMENTS AND CONTROL OF REARING ESTABLISHMENTS Art. 7. the State Secretary of Agriculture or competent animal health authority in ac- Art. 10. All swine-rearing establishments will cordance with both the national model and in- be subject to Official Veterinary Service inspection. structions established by the DSA will register all Art. 11. In the event of non-compliance with swine-rearing establishments. the requirements of this Regulation, the follow- Sole paragraph. The registration of swine- ing measures may be adopted according to the 329 rearing establishments will be carried out an- criteria of the Official Veterinary Service: nually. I – The suspension of importation and exportation permit and the issuance of permits for CHAPTER V domestic transportation; II – Interdiction of the establishment; CONCERNING SURVEILLANCE AND III – Sanitary slaughter; THE NOTIFICATION OF DISEASES IV – Sacrifice and destruction of the animals; Art. 8. The Official Veterinary Service will V – Application of other sanitary measures maintain a system of zoo-sanitary surveillance established by the DSA. and information covering all levels, as well as carrying out systematic analysis of collected data CHAPTER VII and periodic notifications in order to comply with national and international obligations. CONCERNING ANIMALS FOR BREEDING Art. 9. Any veterinarian, owner, animal AND ANIMAL REPRODUCTION MATERIALS transporter or any other citizen who suspects the outbreak of a listed swine disease must notify Art. 12. The commercialisation and distri- the Official Veterinary Service immediately. The bution, in National Territory, of pigs destined for breeding, as well as participation in exposi- CHAPTER IX tions, fairs and auctions, will only be permitted for those animals derived from farms certified CONCERNING EXPOSITIONS, FAIRS by the Ministry of Agriculture, Livestock and AND AUCTIONS Supply (MAPA). Art. 13. All specific norms in force must be Art. 16. All specific norms in force must be observed in relation to the importation of pigs observed for the participation of pigs in exposi- and their animal reproduction materials. tions, fairs and auctions.

CHAPTER VIII CHAPTER X

CONCERNING THE TRANSPORTATION CONCERNING GENERAL ARRANGEMENTS OF ANIMALS Art. 17. As part of the National Swine Health Art. 14. Pigs may only be transported Program, a Technical and Scientific Committee within National Territory when accompanied will be created to assist he DSA in matters specifi- by specific transportation documentation de- cally relating to this Regulation. fined by the DSA in accordance with all rel- Art. 18. The State Secretaries of Agriculture or evant norms. competent animal heath authorities of the States Art. 15. Pig transporter vehicles and their will promote, by way of effective measures, the drivers must be registered by the Official Veteri- creation of State Committees of Animal Health nary Service. and private funds to compensate pig owners af- Paragraph 1. These vehicles must be washed fected by sanitary measures relating to sanitary and disinfected in accordance with the specific slaughter, sacrifice or destruction of property. norms in force. Art. 19. Field actions, the use of vaccines, Paragraph 2. The registration of pig trans- disease diagnosis and the classification of diseas- porter vehicles and their drivers must be re- es to be controlled or eradicated will be defined newed annually. by the DSA in specific legislation.

330

NORMATIVE INSTRUCTION No. 27 OF APRIL 20, 2004.

Published in the Official Gazette of April 27, 2004 Section 1, Page 7

Approves the Contingency Plan for Classical Swine Fever, which shall be effective throughout the national territory, as provided for in the Annex to this Normative Instruction

THE SECRETARY OF AGRICULTURE AND LIVE- tary Health And Inspection Regulation, approved STOCK HEALTH AND INSPECTION OF THE MINISTRY by Decree No. 24,548, of July 3, 1934, and OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, Considering the existence of a Zone Free of in accordance with the duties and responsibilities the Classical Swine Fever in the Country, as de- assigned thereto by Article 15, item II, Annex I, clared by Normative Instruction No. 01, of January Decree No. 4,629, of March 21, 2003, and in com- 4, 2001, and in accordance with Judicial Proceed- pliance with the provisions of the Animal Sani- ing No. 21000.001074/2006-37, hereby resolves: Art. 1. To approve the CONTINGENCY PLAN for in the Annex to this Normative Instruction. FOR CLASSICAL SWINE FEVER, which shall be effec- Art. 2. This Normative Instruction shall en- tive throughout the national territory, as provided ter into force on the date of publication thereof.

MAÇAO TADANO

ANNEX

I. DEFINITIONS his/her custody one or more pigs. 1. Rearing establishment means the places 11. Quarantine means the transit restriction where pigs are maintained or reared for any and observation of groups of apparently healthy purpose. animals that are exposed to the risk of infection 2. Outbreak means the rearing establishment and that, at the moment in question, have no di- or any other place where the presence of one or rect contact with infected animals. The purpose more pigs infected with CSF has been detected. of the quarantine is to prevent possible chain 3. Interdiction means prohibiting pigs as transmission of the disease to other animals that well as products or byproducts thereof or materi- are not directly exposed to it. als that could be a potential source of transmis- 12. Sacrifice and destruction means the sion of the disease, at the discretion of the Offi- operation carried out by the Official Veterinary cial Veterinary Service, from entering and exiting Service when an outbreak of CSF is confirmed. It a rearing establishment for any purpose. consists in killing all sick, contact and contami- 4. Official laboratory means the laboratory nated animals in the herd and, if necessary, other belonging to the network of the Ministry of Agri- herds that have been exposed to the infection by culture, Livestock and Food Supply. direct or indirect contact with the pathogenic 5. Slaughterhouse means the facilities used agent, and destroying the carcasses by incinera- for slaughtering animals intended for human tion or burial. consumption or other purposes and which are 13. Official Veterinary Service means the submitted to official veterinary inspection. federal, state or municipal animal sanitary and 6. Accredited veterinarian means the profes- Inspection agency. 331 sional accredited by the Official Veterinary Ser- 14. Pig means all varieties of Sus scrofa, (both vice, pursuant to specific legislation. domestic and wild pigs). 7. Official veterinarian means the profes- 15. Pig infected with CSF means any swine in sional of the Official Veterinary Service. which clinical symptoms or signs consistent with 8. Classical Swine Fever (CSF) means the com- CSF have been officially detected and the diagno- municable disease caused by a pestivirus that in- sis confirmed by laboratory tests. fects pigs. 16. Pig with suspicion of having been 9. Contingency Plan means the set of emer- infected with CSF means any pig with clinical gency procedures and decisions to be made in symptoms or signs consistent with CSF, or a reac- the case of unexpected outbreak of a outbreak, tion to a laboratory test indicating the possible for the purpose of controlling and eradicating presence of CSF. the CSF agent as soon as possible, thus reducing 17. External surveillance zone means the as much as possible consequent productive and area established by the Official Veterinary Service economic losses. around the internal protection zone, within a 10. Owner means any natural person or le- minimum radius of 10 km from the outbreak. gal entity that is either the owner, depositary, or 18. Internal protection zone means the area at any other title, holds in his/her power or under adjacent to a outbreak, the limits of which will be established by the Official Veterinary Service, be strong, quick and effective. It becomes there- with due regard for geographic and epidemiolog- fore necessary to have an appropriate organiza- ical factors, within a minimum radius of 3 km. tion, trained personnel, legal support, suitable 19. Zone free of CSF means the zone where equipment and materials, and sufficient funds. the absence of the disease has been demon- Classical Swine Fever is classified as a disease strated according to the recommendations of the in the A list of the World Organization for Animal International Zoosanitary Code of the World Or- Health (OIE) and its occurrence results in seri- ganization for Animal Health (OIE). ous consequences to animal welfare, the swine II – INTRODUCTION production, the exporting of animals and prod- 1. Background ucts thereof, and the environment. This disease The activities to combat Classical Swine Fe- in highly contagious, has a great power of dis- ver (CSF) were first introduced in priority zones semination, is especially serious and may extend selected according to the economic relevance of beyond national borders, causing serious socio- the swine producing zone and based on the exis- economic and sanitary damages or hindering or tence of epidemiological conditions favorable for disabling the international trade of animals and obtaining free zones, for the ultimate purpose of products of animal origin. eradicating the disease in the national territory. 3. Objective The National Program for the Control and The objective here is to guide actions and Eradication of Classical Swine Fever was intro- procedures towards the early and immediate duced in 1992, initially in adjacent municipalities notification and confirmation of suspected out- in the states of Rio Grande do Sul, Santa Catarina breaks of Classical Swine Fever in the national and Paraná. The Program was gradually extend- territory, by taking the necessary sanitary and ed to other municipalities in these three states Inspection measures aimed at eradicating the and later on to the other Brazilian states. disease within the shortest time possible, and re- On January 4, 2001, through Normative suming the sanitary condition of free of CSF. For Instruction No. 1, the Brazilian Minister of Agri- this objective to be achieved, it is indispensable to culture, Livestock and Food Supply declared the have a CONTINGENCY PLAN in place establishing, region formed by the States of Rio Grande do Sul, step-by-step, the required sanitary measures. Santa Catarina, Paraná, São Paulo, Minas Gerais, III. EPIDEMIOLOGICAL CHARACTERIZA- Mato Grosso do Sul, Mato Grosso, Goiás, Tocan- TIONS 332 tins, Rio de Janeiro, Espírito Santo, Bahia, Sergipe 1. Minimum sanitary conditions and the Federal District as a Zone Free of Classical In most countries, the prevailing zoosanitary Swine Fever. management strategy is outbreaked on designing 2. Justification and applying measures that minimize the risk of Regardless of how strict the protection sani- introduction or reintroduction of a disease in a tary measures taken by a country, a region or a free country or zone. zone free of a disease might be, there is no abso- Effective activities of different natures are lute guarantee that the infectious agent will not required to minimize the risk of CSF reintroduc- be introduced or reintroduced. tion and to enable the immediate detection and Nowadays, as a result of technological ad- adoption of the necessary measures to eradicate vances, the international transit of people, ani- any possible outbreak. The Official Veterinary mals and animal reproduction materials as well Service should be underpinned in the following as products and byproducts of animal origin has conditions: grown significantly, thus increasing the risk of - Appropriate operational framework; disseminating diseases among countries. - Sufficient financial resources; When a disease is introduced in a country or - Legal support for the actions, provided for zone that had so far been free of such disease, the in specific legislation; actions to be taken in order to eradicate it must - Human and material resources and equipment for effective epidemiological surveillance tation trucks after unloading in slaughterhouses; and veterinary care; these actions should be inspected at fixed and - Personnel trained in sanitary emergency, mobile posts, with a view to controlling the with an emphasis on CSF; transit of animals and products and byproducts - Permanent and effective Sanitary Educa- thereof; tion Program, so as to ensure effective communi- - Effective action by the State Swine Health ty participation. Farmers should be aware of and Committee; motivated towards the actions developed and - Performance of periodic serum epidemio- recognize the relevance of each of such actions; logical inquiries for keeping the Zone Free of CSF; - Pig identification tracing system, which is - Control and inspection of pig transit, prod- a fundamental action for the successful manage- ucts and byproducts thereof, pathological and ment of sanitary emergencies; biological products; - Prohibition to raise pigs in city dumps; - Sanitary surveillance in ports, airports, - Control the use of leftovers to feed pig; frontier posts and collis posteaux; - Interaction between the Official Federal, - Control and inspection of areas of pig con- State and Municipal Inspection and Animal Sani- centration; tary Health and Inspection Services, with a view - Updated sanitary requirements for autho- to the immediate exchange of information in rizing the importing of pigs, animal reproduction case of suspicion of CSF; materials (semen and embryos), and of products - Information system that enables the timely and byproducts of pig origin; adoption of sanitary measures to prevent and - CSF diagnosis laboratories capable of per- control animal diseases; forming the tests with the necessary swiftness - Exchange of sanitary information among the and efficacy; and sanitary departments of corporations/integrating - Maintenance of a strategic stock of vaccine cooperatives, accredited and private sector veteri- against CSF. narians and the Official Veterinary Service; 2. Epidemiological situations - Active surveillance of independent swine The actions of the animal sanitary health and culture, including in subsistence farming; inspection system are based on the existing level - Updated register of swine breeders and of sanitary risk in each situation, as follows: transporters; 2.1 RISK I 333 - Support from agencies and entities linked • Absence of CSF outbreaks in the past 12 to the swine production chain and public bod- months; ies (City Halls, the Military Police, Finance Secre- • All minimum conditions are met; tariat, etc.); • Situation in the states that make up the - Updated list of risk sites: agroindustries, zone free of CSF. slaughterhouses, landfills, dairy industries, pet 2.2 RISK II food industries, agriculture and livestock shops, • Absence of CSF outbreaks in the past 12 bus stations, airports, ports, tanning establish- months; ments, etc.; • All minimum conditions are met; - Permanent monitoring and evaluation of • Characterized by the identification of in- animal health activities, with a view to ensuring ternal and/or external sanitary risks that could the standardization of actions; lead to the reintroduction of CSF. - Effective official follow-up of the sanitary In this situation, depending on the risk as- activities adopted in Accredited Swine Breeding sessment, the Official Veterinary Service can de- Farms (ASBF); clare a “state of animal sanitary emergency” and - Funds for payment of compensations for all actions related to the minimum risk situation the sacrifice and destruction of herds and things; should be taken and those related to the items - Cleaning and disinfection of pig transpor- below strengthened: - Epidemiological surveillance; - To request, where necessary, the technical - Serological investigation; assistance and cooperation of national or inter- - Control and inspection of animal concen- national consultancy; tration sites; - To appoint an epidemiologist to advise the - Control and inspection of interstate transit Field Coordinator. by mobile teams; 2. Duties and responsibilities of the Coor- - Control and inspection of the entry of dination Units animals, animal reproduction materials, prod- 2.1. General Coordination Unit ucts and byproducts of swine origin, people and a) To mobilize and coordinate the emergen- equipment in ports, airports, and frontier posts; cy team and required professionals; - Control and inspection of the entry of b) To involve the institutions and entities aircrafts, vessels and terrestrial vehicles coming that will participate in the works; from abroad; c) To establish the evaluation and taxation - Exchange of sanitary information among committee, comprised of a representative of the countries. Production Sector, a representative of the federal 2.3. RISK III Official Veterinary Service, and a representative • Characterized by the emergence of CSF of the state Official Veterinary Service. outbreaks – SANITARY EMERGENCY. 2.2. Field Coordination Unit IV. SANITARY EMERGENCY a) To coordinate all daily operations related Is the set of sanitary actions aimed at pre- to field emergencies and the action strategies ad- venting dissemination of the disease and eradi- opted; cating the CSF outbreak within the shortest time b) To appoint and oversee the following possible and at the lowest cost for the country. committees: These actions should be carried out by a group of - Epidemiological surveillance: responsible professionals trained in sanitary emergency. for the information system as well as for activities V. SANITARY EMERGENCY TEAM involving tracing, inspection, the use of sentinel The sanitary emergency team should be es- animals, repopulation, quarantine, animal tran- tablished by legal act and comprised of profes- sit, installation of fixed and mobile posts, and sionals from the federal and state Official Veteri- control of animal concentration sites; nary Services and include, as a minimum a(n): - Sacrifice and destruction; 334 - General Coordination Unit; - Cleaning and disinfection of facilities and - Field Coordination Unit; vehicles and other biosecurity procedures; - Laboratory Coordination Unit; - Communication and sanitary education; - Administrative/Financial Coordination Note: The heads of these committees will Unit; be in charge of leading and executing the actions - Communications and Public Relations Co- related to their tasks, so as to achieve the specific ordination Unit; objectives thereof. - Legal Affairs Coordination Unit. c) To ensure logistic support for the com- 1. Responsibilities of the sanitary emer- mittees; gency team d) To demarcate protection and surveillance - To implement the animal sanitary health areas as well as areas for the establishment of and inspection policy determined by the Contin- fixed and mobile posts; gency Plan; e) To make contact with authorities and oth- - To request, where necessary, the collabora- er local segments that could provide assistance or tion of representatives of other sectors involved be linked to the swine sector; in the eradication and meet with these regularly, f) To ensure that all field reports are prepared so as to follow up and evaluate all aspects related and submitted to the General Coordination Unit to field operations; in a timely manner. 2.3. Laboratory Coordination Unit: such as geographic location, natural barriers, To work with the Field Coordination Unit so access routes, registration data, type of rearing as to ensure that samples are properly collected, establishment, neighboring establishments, ex- processed, identified, packed and dispatched. isting swine population, entry and exit of ani- 2.4. Administrative and Financial Coordina- mals in the past 30 days, production data, pre- tion Unit: viously notified diseases, slaughterhouses and To work with the General Coordination Unit establishments selling products and byproducts with a view to preparing budgets and procuring, of swine origin; distributing and ensuring the supply of materials - To inform the sanitary management im- and services. mediately; To coordinate and manage the evaluation - To have the materials and equipment re- and taxation committee. quired to handle an outbreak(Annex I) as well as 2.5. Communications and Public Relations the following documents: FORM-IN, Term of Visit Coordination Unit: to the Swine Farm, and Interdiction Notice. To work with the General and Field Coordi- 3 – Visit to the farm suspected of CSF nation Units by providing information and ensur- a) To organize the visit on a priority basis, no ing that this reaches the media and competent later than 12 hours after notification, and follow authorities in a properly manner. the procedures below: 2.6. Legal Affairs Coordination Unit: - First of all, visit the rearing establishment To advise the General and Field Coordination suspected of CSF by going straight to the main Units with respect to legal matters and handle all house, office or management, in order to collect legal processes inherent in sanitary emergencies. information from the owner or person in charge. VI. OPERATION PROCEDURES IN VETERI- Avoid driving an official vehicle into the property; NARY CARE - Change clothes, wearing preferably dis- 1. Notification of suspicion posable clothes and using disposable materials - A permanent information system shall be when entering the premises where the animals maintained on a permanent basis, so that dis- are kept; ease outbreaks can be promptly notified and - Fill out the Term of Visit to a Swine Farm; handled; - Perform the clinical examination of sick - Every veterinarian, owner and transporter animals with the assistance of a minimum of of- 335 of animals, or any other citizen aware of a sus- ficial or private staff and avoid moving or group- pected outbreak of CSF or of any other disease ing susceptible animals; with a similar clinical picture should, pursuant - Investigate the establishment and per- to the legislation in force, immediately notify the form a clinical examination in apparently closest unit of the Official Veterinary Service; healthy animals; - The notification can be provided personally, - Where the suspicion is unquestionable and by telephone, fax or any other available media. confirmed, fill out the FORM-IN and the Interdic- 2. Attention to the notification tion Notice, collect samples and communicate the - Where the person providing the notification sanitary authority immediately, so that all neces- is the owner or person in charge, he/she should sary emergency actions can be promptly taken; be informed of the prohibition to move pigs and - Send the material collected to the labora- products and byproducts thereof from the farm, tory at: until the Official Veterinary Service has defined Laboratorio de Apoio Animal – LAPA/RECIFE the measures to be taken; Address: Rua Dom Manoel de Medeiros, s/No. - To record the fact, including date and time, Dois Irmãos – Campus UFPE in the Local Unit’s log; CEP: 52171 - 030 - To gather as much information as possible RECIFE – PE on the rearing establishment under suspicion, TELEPHONE: (081) 3441-6311 IMPORTANT: Inform the LAPA/Recife imme- VII. DETERMINATION OF THE AFFECTED diately of the airway bill number as well as the ZONE AND SANITARY MEASURES TO BE TAKEN flight number and time of arrival of the material. IN THE CSF OUTBREAK b) To collect the material Where the laboratory diagnosis is positive - Collect blood samples from sick and healthy for CSF or the suspicion is unquestionable and animals so as to compare antibody titers for the confirmed, the emergency team should be called CSF virus. For the serological diagnosis, send to in so that the Contingency Plan can be executed the laboratory clear serums, free of hemolysis, and the necessary legal measures taken. at a minimum of 3 ml per animal. The serums Where a CSF outbreak is confirmed in ex- should be frozen and immediately sent to the hibit, fair or auction facilities or other sites of Laboratório de Apoio Animal (Animal Support swine concentration, the whole area should be Laboratory) – LAPA – Recife/PE; considered an outbreak and be subject, as ap- - Sacrifice sick animals and collect samples propriate, to the sanitary measures provided of tissues, preferably tonsils, spleen, pharynx and for in this Contingency Plan. mesenteric ganglions and distal portion of the The General Coordination Unit will request ilium, in the following conditions: the cooperation of public entities and agencies • Send at least 20 grams of each organ; (the military police, city halls and others), with • Send organ fragments in separate plastic a view to ensuring isolation of the outbreak, bags properly identified by animal; strengthening preventive sanitary measures • Pack samples under refrigeration and and guaranteeing implementation of the Con- send them immediately to the LAPA –Recife/PE. tingency Plan. If it is not possible to have the material arrive at The Field Coordination Unit will immediately the Laboratory within 48 hours after collection, determine the following actions: freeze the material; a) Establishment of the main office head- • All collected materials should be listed in quarters; the FORM-IN and carefully identified with a label b) Establishment of the following areas of or adhesive tape written in pencil, and protected action: with transparent tape. - Outbreak - Each and every collection of suspected ma- - Internal protection zone terial should follow the rules of the LAPA – Rec- - External surveillance zone 336 ife/PE and be sent accompanied with the FORM- c) Establishment of fixed and mobile inspec- IN and a memorandum forwarding the material tion posts in the affected zone; and requesting the tests and indicating the num- d) Review of the demarcation of the affected ber and type of samples being sent. zone, with possible expansion thereof, according - Arrange for the destruction (burial or cre- to the information collected during inspections/ mation) of the carcasses of the animals sacrificed investigations; for sample collecting purposes. e) Placement of interdiction signs in strategic - When leaving the suspected establishment, locations; clean up and disinfect the equipment and ma- f) Inspection of rearing establishments and terials used in clinical examinations and sample swine slaughterhouses located in the internal collections, doing the same to the vehicle. Incin- protection and external surveillance zones; erate all disposable working clothes. g) Composition of the committees in charge - Where the laboratory result is negative for of emergency actions. CSF, interdiction of the establishment should be VIII. PROCEDURES TO BE ADOPTED DURING suspended, but the epidemiological surveillance A SANITARY EMERGENCY should be maintained for 21 days. The samples 1. Measures related to the outbreak will be used for a differential diagnosis, which 1.1 Evaluation of animals, products and ma- will determine the measures to be taken. terials Exposed animals as well as contaminated a way so as to allow the Sacrifice and Destruction products and materials should be previously Committee to arrive at the site after completion evaluated before sacrifice and destruction. of the preliminary work; The evaluation will be performed by the cor- - Caliber 22 firearms can be used to kill sick responding committee and the values recorded animals and their contacts, with a shot in the in the Term of Evaluation, which will contain all cranial region or other appropriate method. The the criteria used (race, age, gender, identification animals should be sacrificed inside trenches and and weight among others). their abdominal cavities open; Any dispute with respect to the values as- - Any unnecessary movement of the animals signed will not prevent the sanitary action from should be avoided and care should be taken to going forward. prevent them from escaping when being con- 1.2. Sacrifice and Destruction: ducted to the trenches. a) Pigs infected with CSF and direct con- 1.3. Destruction of sacrificed animals tacts thereof will be submitted to sacrifice and The place for the destruction of sacrificed destruction in breeding establishment itself or in animals should be carefully selected, according any other suitable location, at the discretion of to the directions of the environmental protection the Field Coordinator, after having been evalu- agency. Factors such as soil condition, proxim- ated and within no more than 24 hours after re- ity to the outbreak, safety of facilities, dominant ceipt of the sacrifice order issued by the Animal winds and isolation of the area to avoid public Health and Inspection Department (DDA); presence should be taken into account. b) Indirect contact pigs housed in the 1.3.1 - Cremation same rearing establishment (outbreak) will be a) A shallow trench, no deeper than one submitted to a risk assessment and may be meter, should be excavated. A layer of firewood sent for sacrifice and destruction or sanitary or thick wood should be placed diagonally in slaughter. the trench, which should be filled with straw, In the case of sanitary slaughter, contact thin wood or charcoal soaked in kerosene or animals will be sent to slaughterhouses subject diesel oil; to federal or state inspection, at the discretion of b) The dead animals should be lined up on the Official Veterinary Service. this layer of firewood, alternating head and tail. c) In the case of sacrifice and destruction Additional wood or charcoal soaked in diesel or 337 of pigs, the provisions of specific legislations kerosene should be placed over and around the should apply; dead animals. Use a torch launched from a safe d) These tasks are performed by the Sacri- distance or a gunpowder trail to light the fire; fice and Destruction Committee under the su- c) Estimates show that cremating 250 adult pervision of an official veterinarian, and public pigs requires around 6 tons of charcoal, ½ a ton access to the site should be prevented by the of wood, 75 liters of diesel, and 45 kilos of straw military police; or thin wood; e) Operationalization: d) Cremation should be followed by burial; - Written notification should be sent to the the entire process should be monitored by the of- owner of the animals to be destroyed, with the ficial service. necessary details to prevent the work from being 1.3.2 – Burial delayed; a) The trenches should be built preferably - The sacrifice will be carried out by mem- in the dominant direction of the winds, and be bers of the armed or public security forces, with 2.5 meters deep and 2.5 meters wide. The length subsequent destruction of the carcasses by burial will depend on the number of animals – 1.5 me- and/or cremation. Burial is, in general, the most ter per each 5 adult pig. Dead animals should be suitable and practical method; laid down side by side, alternating head and tail; - The operation should be scheduled in such b) The ramp down the trench should be smooth. Lime should not be used, as it delays the entry, under strict control, of susceptible animals natural decomposition process that favors inacti- is authorized, so as to prove the absence of viral vation of the virus; activity in the environment; c) Once the trenches have been covered, it is - The introduction of sentinel pigs in the out- recommended that the area be surrounded with break under eradication will start after the end a wire net, so as to prevent small animals from of the downtime and the adoption of other mea- approaching and excavating the site; sures provided for in this Contingency Plan. It d) It is recommended that the trenches should start with 5% cent of the population that and adjacent areas be inspected at least once a existed in the outbreak or at least 5 pigs no older week, until the rearing establishment has been than 60 days. These animals should be distrib- repopulated. uted in such a way so as to cover all premises in 1.4 – Clean-up and Disinfection the rearing establishment; Clean-up and disinfection are very impor- - The sentinel pig must have been born and tant operations to ensure the inactivation of an resided in farms officially recognized as free of infecting agent in a establishment and, conse- CSF. Pigs born and raised in rearing establish- quently, to prevent the disease from disseminat- ments with a different sanitary status should be ing. They include preliminary disinfection, fol- submitted to individual serological control; the lowed by thorough cleaning and washing and, presence of antibodies specific to the CSF virus finally, definitive disinfection. The material col- should not be detected; lected in the facilities after the first disinfection - Sentinel pigs should be identified by eart- operation should be completely destroyed by ags and will be submitted to individual serologi- burial or cremation. cal control at 15 and 30 days from the date of Following the sacrifice and burial or crema- introduction, with the objective of detection of tion, all machines, equipment and materials used antibodies specific to the CSF virus; by the team that carried out the work should be - Sentinel pigs will remain in the property disinfected using one of the following products: until the second laboratory report is received, a) Phenol at 3%; showing negative results. During this time, the b) Strong iodophors (1%) in phosphoric acid; animals should be submitted to weekly clinical c) Cresol; examinations, with their body temperature tak- d) Sodium hydroxide at 2%; en. Cleaning and disinfection measures should 338 e) Formalin at 1%; be maintained for those entering or exiting the f) Sodium carbonate ( 4% anhydrous or 10 % rearing establishment. crystalline, with 0.1 % detergent); c) Control of sentinel animals g) Ionic and non-ionic detergents; Where a sentinel pig yields a positive sero- 1.5 – Downtime, introduction of sentinels logical result, all the other animals will be killed, and repopulation and the process of cleaning, disinfection, down- a) Downtime time and new introduction of sentinels will be Downtime is the time period between the restarted; completion of cleaning and disinfection and the Where sentinel pigs yields negative serologi- introduction of sentinel pigs, with the objective cal result, the animals should be sent for slaugh- of destroying the natural infectious agent in the ter in a slaughterhouse subject to federal inspec- environment. This stage should last a minimum tion and the repopulation process will start. of 10 days and during this time other disinfection d) Repopulation operations can be performed. Repopulation of the rearing establishment b) Introduction of sentinel pigs will only be authorized after the results of the - Cleaning, disinfection and downtime do second serology of pig sentinels, yielding nega- not fully guarantee the destruction of the CSF vi- tive results, are received. After this period of time, rus in an infected establishment. As a result, the the establishment will be released. 2. Epidemiological Tracing c) As regards slaughterhouses and byproduct Once the outbreak has been confirmed, a industries: quick and effective field tracing should be per- - Trace fresh, cold or frozen products and by- formed and the transit of animals, products and products of animal origin. The transit should be byproducts of pig origin should be assessed, with evaluated by risk analysis as a potential factor of the objective of controlling the situation by de- disease dissemination. termining the origin of the outbreak. Tracing is d) Veterinarians and independent profes- necessary to enable identifying the herds exposed sionals linked to the field, who perform their ac- and prevent the disease from spreading. tivities in the infected zone should be informed It should be performed by a specific team of the presence of the disease and provide the Of- in each zone (zones of internal protection and ficial Veterinary Service with a list of all the rear- external surveillance) and in other areas as well, ing establishments visited in the past seven days. when the investigation so recommends. Tracing 3. Measures to be taken in the internal in those other areas will be determined by the protection zone Field Coordinator and will be under the responsi- - Prohibit the transit of pigs from establish- bility of the corresponding Local Unit. ments located in the internal protection zone as Depending on the transit survey, tracing can well as the transit of materials that could be con- require a large number of people, under system- taminated, such as animal food and excrements atic and careful coordination. originating in the internal protection zone; Aspects to be traced: - Immediately perform the epidemiological a) Previous facts relating to the origin of the tracing; outbreak, as well as its possible dissemination to - Permit only the transit of clean and disin- other establishments and municipalities in the fected vehicles and equipment, pursuant to the 30 days before the disease was detected, with procedures defined by the Official Veterinary an investigation of the transit of animals and Service following inspection by the Official Vet- people, transportation of products, fairs, slaugh- erinary Service; terhouses and buyers that had contact with the - The transit of animals of other species from infected establishment before the restrictions rearing establishments located in the internal pro- had been defined. tection zone as well as the entry of animals in those b) As regards the transit of pigs, reproduction same rearing establishments will only be permitted 339 materials, products and byproducts of swine origin: if authorized by the Official Veterinary Service. - If the establishment is being disinfected 3.1 – Actions to be developed: for some time already, all possible information 3.1.1 – Interdiction: on the movement of pigs, products and byprod- In the internal protection zone, the inter- ucts thereof, excrements, equipment belonging diction period of any rearing establishment will to the rearing establishment, vehicles, food left- be of up to 21 days after completion of the pre- overs, people, pets and other relevant informa- liminary outbreak cleaning and disinfection option should be obtained from the owner and his/ erations. The animals may be sent for slaughter, her employees immediately after confirmation of subject to a risk assessment and control by the the diagnosis and together with the beginning of Official Veterinary Service. eradication actions; In the interdiction process, the quarantine - Determine the date, type of transit and des- may be one of the following: tination with the exact location, so as to ensure • Full quarantine: full restriction of animal the quick identification of the rearing establish- transit for a minimum period of 21 days; ments exposed; • Short quarantine: selective restriction of - Record on the municipality’s map, in de- the transit of animal and products and byprod- tails, the transit involving existing rearing estab- ucts of animal origin. It is generally applied ac- lishments. cording to actual or presumed differences in sus- ceptibility and justifiable economic reasons. pigs directly to slaughterhouses under federal or 3.1.2. Population census state inspection, provided that the following con- The Official Veterinary Service should carry ditions are satisfied: out a census of the pig population existing in all - Inspection of all pigs in the rearing estab- establishments located in the zone, no later than lishment; seven days after establishment thereof. - Clinical examination of pigs intended for a) Controlling the Transit of Pigs and Animal immediate slaughter, including taking the tem- Reproduction Material perature of some animals selected at the discre- I. Restriction involving the circulation and tion of the official veterinarian; transportation of pigs and animal reproduc- - Identification of the animals by the official tion material in public or private routes. This veterinarian, using eartags or any other approved restriction may not be applied in the following identification system; situations: - Transport of the animals in disinfected and Transit through the internal protection zone sealed vehicles, accompanied with the Animal by road or railway, without stops or unloading Movement Permit (GTA), with identification of therein; the route on the back thereof; Pigs originating outside the internal protec- - Communication to sanitary authority re- tion zone and intended directly to slaughterhous- sponsible for the slaughterhouse; es located in the same zone, as long as they are - Upon arrival in the slaughterhouse, pigs transported in vehicles sealed in the origin by the originating in the internal protection zone should Official Veterinary Service. be kept isolated and be slaughtered at the end II. Restriction involving the transit of animals of the killing. During ante- and post-mortem in- of other species originating in establishments lo- spection, the sanitary authority should look for cated in the internal protection zone. signs and injuries related to the presence of in- III. Prohibition to take pigs and animal re- fection by the CSF virus; production material out of any breeding estab- - The vehicle and equipment used to trans- lishments, up to 21 days after completion of the port the pigs should be immediately washed and preliminary cleaning and disinfection operations disinfected, under the supervision of the official in the outbreak. The animals may be sent for veterinarian. slaughter, subject to a risk assessment and con- II. To rearing establishments within the in- 340 trol by the Official Veterinary Service. ternal protection zone 3.1.3. Transit of products and byproducts of Twenty one days after completion of the swine origin and other materials preliminary cleaning and disinfection operations Only the transit of clean and disinfected in the outbreak and subject to a risk assessment, vehicles and equipment will be permitted, pur- the Official Veterinary Service may authorize the suant to the procedures defined by the Official removal of pigs from establishments located in Veterinary Service following inspection by an of- the internal protection zone, directly to another ficial employee. rearing establishment in the same zone, provided The transit of materials that could be con- that the following conditions are satisfied: taminated such as animal food, excrements and - Inspection of all pigs in the rearing estab- garbage leak originating in the internal protec- lishment; tion zone, as well as in any rearing establishment - Clinical examination of the pigs to be re- or slaughterhouse. moved, including taking the temperature of 3.1.3.1. Permission for the removal of pigs some animals selected at the discretion of the I. Directly to slaughterhouses official veterinarian; At the end of the epidemiological tracing - Identification of the animals by the official period and after the risk assessment, the Official veterinarian, using eartags or any other approved Veterinary Service may authorize the removal of identification system; - Cleaning and disinfection, after each op- Transit through the external surveillance eration, of the vehicles and equipment used to zone by road or railway, without stops or unload- transport pigs. ing therein; 3.1.4 – Maintenance of measures: Pigs originating outside the internal protec- The measures applied in the internal protection zone and intended directly to slaughterhous- tion zone will be maintained until the established es located in the same zone, as long as they are actions have been completed and a serological transported in vehicles sealed in the origin by the inquiry comprising all the rearing establishments Official Veterinary Service. in the zone has been performed. This inquiry will II. Restriction involving the transit of animals be performed when at least 30 days have elapsed of other species originating in establishments lo- after completion of the preliminary cleaning and cated in the external surveillance zone. disinfection operations in the outbreak, according III. Prohibition to take pigs and animal re- to a sample to be defined by the Animal Health production material out of any rearing estab- and Inspection Department of the Ministry of Ag- lishments, up to 21 days after completion of the riculture, Livestock and Food Supply (DDA/MAPA), preliminary cleaning and disinfection operations and no antibodies specific to the CSF virus have in the outbreak. The animals may be sent for been detected. slaughter subject to a risk assessment and control 4. Measures to be taken in the external by the Official Veterinary Service. surveillance zone 4.1.3.1. Permission for the removal of pigs 4.1. Action to be developed: I. Directly to Slaughterhouses 4.1.1. Interdiction: The Official Veterinary Service may authorize In the external surveillance zone, the inter- the removal of pigs directly to slaughterhouses diction period of any rearing establishment will subject to federal or state inspection, preferably be of up to 10 days after completion of the pre- located in the internal protection zone or in the liminary outbreak cleaning and disinfection op- external surveillance zone, provided that the fol- erations. The animals may be sent for slaughter lowing conditions are satisfied: subject to a risk assessment and control by the - Inspection of all pigs in the rearing estab- Official Veterinary Service. lishment; In the interdiction process, the quarantine - Clinical examination of the pigs intended may be one of the following: for immediate slaughter, including taking the 341 • Full quarantine: full restriction of animal temperature of some animals selected at the dis- transit for a minimum period of 21 days; cretion of the official veterinarian; • Short quarantine: selective restriction of - Identification of the animals by the official the transit of animal and products and byprod- veterinarian, using eartags or any other approved ucts of animal origin. It is generally applied ac- identification system; cording to actual or presumed differences in sus- - Transport of the animals in disinfected and ceptibility and justifiable economic reasons. sealed vehicles, accompanied with the Animal 4.1.2. Population census Movement Permit (GTA), with identification of The Official Veterinary Service should carry the route on the back thereof; out a census of the pig population existing in all - Communication to the sanitary authority establishments located in the zone, no later than responsible for the slaughterhouse; seven days after establishment thereof. - Upon arrival in the slaughterhouse, pigs 4.1.3. Transit of products and byproducts of originating in the internal protection zone should swine origin and other materials be kept isolated and slaughtered at the end of I. Restriction involving the circulation and the killing. During ante- and post-mortem inspec- transportation of pigs and animal reproduction tion, the sanitary authority should look for signs material in public or private routes. This restriction and injuries related to the presence of infection may not be applied in the following situations: by the CSF virus; - The vehicle and equipment used to trans- c) Findings suspicious of CSF – where the port the pigs should be immediately washed and ante-mortem examination reveals clinical signs disinfected, under the supervision of the official or findings of injuries consistent with CSF in the veterinarian. slaughter line, the veterinarian responsible for II. To rearing establishments located in the the sanitary inspection in the slaughterhouse will external surveillance zone: take the following measures: Ten days after completion of the preliminary I. Immediately notify the Official Veterinary cleaning and disinfection operations in the out- Service, so that it can perform an epidemiological break and subject to a risk assessment, the Offi- investigation; cial Veterinary Service may authorize the removal II. Immediately slaughter all pigs in the of pigs from establishments located in the exter- slaughterhouse and collect material for labora- nal surveillance zone, directly to another rearing tory diagnosis; establishment in the same zone, provided that III. Collect material from carcasses with inju- the following conditions are satisfied: ries suspicious of CSF and forward it to the labo- - Inspection of all pigs in the rearing estab- ratory; lishment; IV. Destroy, under official control, all - car - Clinical examination of the pigs before casses and offal, so as to prevent CSF from dis- loading, including taking the temperature of seminating. The products could be used under some animals selected at the discretion of the of- certain conditions, after a risk assessment has ficial veterinarian; been performed by the Official Veterinary Ser- - Identification of the animals by the official vice. In this case, the products will be prohibited veterinarian, using eartags or any other approved for exporting; identification system; V. Wash and disinfect all premises and equip- - Cleaning and disinfection, after each opment, including the vehicles used to transport eration, of the vehicles and equipment used to infected pigs, under the surveillance of the vet- transport pigs. erinarian responsible for the sanitary inspection 4.1.4. Maintenance of measures in the slaughterhouse, according to the rules of The measures applied in the in the exter- the Official Veterinary Service; nal surveillance zone will be maintained until VI. Reintroduction of pigs for slaughter in the established actions have been carried out slaughterhouses where CSF outbreaks have been 342 and a serological inquiry comprising all the identified, will only be authorized at least 24 rearing establishments in the zone has been hours after completion of the cleaning and dis- performed. This inquiry will be performed infection operations. when at least 15 days have elapsed after com- 6. Fixed and mobile inspection posts pletion of the preliminary cleaning and disin- These posts are used with the objective of fection operations in the outbreak, according circumscribing an emergency zone using transit to a sample to be defined by the Animal Health control and disinfection measures to prevent CSF and Inspection Department of the Ministry of from spreading. Agriculture, Livestock and Food Supply (DDA/ The main objective of these posts is to en- MAPA), and no antibodies specific to the CSF sure fulfillment of the measures relating to the virus have been detected. transit of animals, product, byproducts, animal 5. Procedures in Slaughterhouses reproduction material, vehicles, people, and a) Receiving of animals from the internal other materials that could transmit the agent be- protection zone – already described in the item tween each of the areas. on internal protection zone. They will be established within the perimeter b) Receiving of animals from the external of each of the demarcated zones and should be surveillance zone – already described in the item in operation within 12 hours after the emergency on external surveillance zone. has been established. The teams that will be working in these posts to be vaccinated; should include representatives of the Official Vet- Duration of the vaccination schedule; erinary Service and of the public security forces Measures applicable to the transportation and be equipped with permanent means of com- of pigs and products thereof; munication with each other and with the Field Identification of vaccinated pigs, in the case Coordination, so as to ensure fulfillment of the of vaccination in rearing establishments located sanitary measures adopted. in a free zone, for subsequent sanitary slaughter; 7. Vaccination against CSF Supervision and follow-up of vaccination by a) In exceptional cases, where the risk of the Official Veterinary Service. CSF dissemination has been determined after an b) In the case of emergency use of vaccine evaluation of the epidemiological situation and against CSF in a free zone or in part of the ter- at the discretion of the Official Veterinary Ser- ritory of a free zone, this will lose the status of vice, the emergency use of vaccine may be au- free, which can only be regained when the con- thorized, subject to a specific plan approved by ditions set out in the OIE International Zoosani- the DDA that includes: tary Code are met. Extension and demarcation of the geograph- c) Only vaccines against CSF registered with ic area where the vaccination will take place; MAPA and produced under the control of the Of- Categories and estimated number of pigs ficial Veterinary Service can be used.

ANNEX I

EQUIPMENT AND MATERIALS FOR EMERGENCY ACTIONS - CSF

Have the following equipment and materials 17) Syringes available, preferably disposable, where possible. 18) Pipe As a good management practice, units of these 19) Thick bow or rope materials, organized in metallic or plastic boxes, 20) Plastic bucket should be permanently ready. 21) Sponge 22) Brush 343 1) Aprons 23) Soap 2) Rubber boots and shoe protectors 24) Sodium carbonate or another agent 3) Impermeable pants, jacket, and cap 25) Portable sprinkling equipment 4) Rubber and/or disposable gloves 26) FORM-IN 5) Cotton and/or paper towels 27) Term of interdiction 6) Clinical thermometers 28) Term of Visit to a Swine Farm 7) Tweezers 29) Box with necropsy instruments 8) Scissors 30) Bags for residues 9) Syringes and needles 31) Means of identification: tattoer, pliers for 10) Gauze eartags, eartags, marking stick 11) Blindfold for containing wild pigs 32) Isothermal boxes and ice 12) Adhesive tape and/or another identification 33) Manual spraying pump label 34) Mechanical spraying pump 13) Pencil and pen 35) Map of the municipality and region 14) Plastic bags for samples 36) GPS 15) Vials and needles for collecting blood 37) Drawing boards 16) 100x20 or 80x15 needles ANNEX II

CHARACTERISTICS OF CLASSICAL SWINE FEVER – OIE

ETIOLOGY South America, parts of Europe and Africa. 1. Classification of the causal agent Virus of the Flaviviridae family, Pestivirus 5. Diagnosis gender. The incubation period of the disease is from 2. Reaction to physical and chemical action 7 to 10 days. Temperature: Partially resistant to moder- a. Clinical diagnosis ate heat (56ºC) • Acute form pH: Inactivated at pH < 3.0 or pH >11.0 - Fever (41ºC), anorexia, lethargy; Chemical products: Sensitive to ether, chlo- - Multifocal Hyperemia and hemorrhagic roform, --propiolactone 0.4% skin injuries, conjunctivitis; Disinfectants: Inactivated by cresol, sodium - Skin cyanosis, especially in the extremities hydroxide (2%), formalin (1%), sodium carbonate (ears, members, snout, tail); (4% anhydrous or 10% crystalline, with 0.1% de- - Intestinal constipation followed by diar- tergent), ionic and non-ionic detergents, strong rhea; iodophors (1%) in phosphoric acid - Vomit; Survival: Survives well in cold environments - Ataxia, paresis and convulsion. Animals pile and can survive some meat processing methods up on top of each other; (cured and smoked) - Death within 5 to 14 days from start of the EPIDEMIOLOGY disease; 1. Hosts - Young animals’ mortality rate close to Domestic and wild pigs are the only natural 100%. reservoirs of the Classical Swine Fever (CSF) virus. • Chronic form 2. Transmission - Prostration, irregular appetite, fever, diar- • Direct contact between animals (secre- rhea; tions, excretions, semen, blood); - Apparent recovery with subsequent relapse 344 • Dissemination by persons, utensils, vehi- and death. cles, clothes, instruments and needles; • Congenital form • Use of food leftovers without appropriate - Congenital tremor and weakness; thermal treatment for animal food; - Stunting and death; • Transplacentary infection. - Clinically normal piglets, but with persis- 3. Virus sources tent viremy and no immunitary response. • Blood and all tissues, secretions and excre- • Mild form (females) tions of sick and dead animals; - Fever and lack of appetite; • Infected piglets have a congenital persis- - Fetal death and re-absorption or mummi- tent viremy and can excrete viruses for months; fication, stillbirth; • Infection paths: ingestion, contact with - Birth of congenitally infected pigs; conjunctives, skin injuries, insemination, percu- - Miscarriage (less frequent). taneous penetration of blood. Injuries 4. Geographic distribution • Acute form The disease is distributed in most of Asia, - Leucopeny and trombocytopeny; - Petechias spread ecchymosis, mainly on - Lymphatic ganglions (pharyngeal and e the skin, in the lymphatic ganglions, larynx, blad- mesenteric) der, kidneys and ileocecal valve; - Spleen - Multifocal infarct on the border of the - Kidneys spleen; - Distal ileum - Hemorrhagic lymphatic ganglions; - Blood in EDTA (live animals) - Encephalomyelitis with perivascular cuffs. • Samples for serological tests: • Chronic form - Samples of animal serum. - Button-shaped ulcers next to the ileocecal PROPHYLAXIS AND PREVENTION valve and the large intestine; There is no possible treatment. Infected pig- - Generalized depression of the lymphoid lets must be sacrifaced and their carcasses buried tissue; or incinerated. - Hemorrhagic and inflammatory injuries 1. Sanitary prophylaxis could be absent. • Effective communication among veteri- • Congenital form nary authorities, independent veterinarians and - Cerebellar hypoplasia, microencephaly, swine producers; pulmonary hypoplasia, hydropsis and other mal- • Efficient disease notification system; formations. • Strict policy for the importing of live pigs, a. Differential diagnosis fresh and cured pork meat; • African swine fever (the clinical-patholog- • Prohibition to use or obligation to adopt ical differentiation is impossible. Material needs adequate thermal treatment for the use of food to be sent for laboratory diagnosis); leftovers for pigs; • Infection by bovine diarrhea virus; • Efficient control over swine slaughterhouses; • Salmonellosis; • Systematic serological surveillance of pigs • Erysipelosis; intended for breeding; • Acute pasteurellosis; • Maintenance of an efficient swine identi- • Other viral encephalomielites; fication system. • Estreptococosis; 2. Medical prophylaxis • Leptospirosis; • Free countries: vaccination is prohibited; • Intoxication by cumarin. • Infected countries: vaccination with modi- 345 b. Laboratory diagnosis fied live virus is efficient to control the disease, • Identification of the agent but by itself will not completely eliminate the - Fluorescent antibody test; infection. - Virus isolation in cellular culture, with de- 3. Measures to be taken in the outbreak tection of the virus by immunofluorescence or • Sacrifice of all infected pigs; immunoperoxidase. Identification confirmed • Elimination of carcasses, beds, excre- with monoclonal antibodies. tions, etc.; • Serological tests • Thorough disinfection; - ELISA • Identification of the infected zone, with - Virus neutralization revealed by peroxidase transit control; or by fluorescent antibodies. • Detailed epidemiological investigation, • Samples for identification of the agent: with tracing of possible sources of infection and should be kept under refrigeration and sent to dissemination of the disease; the laboratory as soon as possible. • Surveillance in the infected zone and sur- - Tonsils rounding region. NORMATIVE INSTRUCTION No. 6 OF MARCH 9, 2004

Published in the Official Gazette of March 10, 2004 Section 1, Page 3

Approves the Rules for Eradication of the Classical Swine Fever (CSF), which shall be complied with throughout the entire National Territory, in the manner described in this Normative Instruction

THE MINISTRY OF STATE OF AGRICULTURE, if authorized, shall be ruled by specific legislation LIVESTOCK AND FOOD SUPPLY, in accordance addressing the matter, and sustained by regularly with the duties and responsibilities assigned issued official certification. thereto by Article 87, subsection II, of the Consti- Art. 4. To delegate authority to the Animal tution, and in compliance with article 71 of the and Plant Health and Inspection Secretariat to Animal Sanitary Health and Inspection Regula- pass supplementary rules to assure thorough im- tion as approved by Decree No. 24,548 of July 3, plementation of CSF eradication activities in the as well as the contents of the Judicial Proceeding country, through proposal/bill submitted by the No. 21000.011262/2003-21, hereby resolves: Animal Health and Inspection Department, which Art. 1. To approve the Rules for Eradication shall include a Contingency Plan setting out spe- of the Classical Swine Fever (CSF), which shall be cific measures to be adopted in the event of the complied with throughout the entire National disease to allow for its immediate elimination. Territory, in the manner described in this Norma- Art. 5. The Animal and Plant Health and tive Instruction. Inspection Secretariat shall carry out activities Art. 2. To forbid vaccination of pigs against to promote the creation and establishment of the CSF in the entire National Territory, except in state committees for swine health, and to raise zones to be defined by the Animal Health and In- private funds to compensate pig owners that spection Department - DDA. are affected by the sanitary measures impli- Art. 3. To forbid the entry or transit, within cating in the slaughter of animals and destruc- the CSF zone free, of pigs, and its products and tion of goods. 346 byproducts, animal multiplication material of Art. 6. State Secretariats for Agriculture or swine origin, pathological and biological prod- competent animal health and inspection author- ucts, and presumable carriers and propagators of ities within the States will promote, through ef- the disease’s virus, coming from infected zones; fective measures, the activities as provided by the with the purpose of maintaining CSF zone frees Rules approved by this Normative Instruction, in the country, in accordance with the principles and the other legal orderings arising from it. ruling zone and regions, as set out by the World Art. 7. This Normative Instruction shall enter Animal Health Organization (OIE). into force on the date of publication thereof. Sole Paragraph. In exceptional cases, the en- Art. 8. This Normative Instruction revokes try or transit of animals referred to in this article, Administrative Ruling No. 201, of May 15, 1998.

ROBERTO RODRIGUES ANNEX

RULES FOR THE ERRADICATION OF CLASSICAL SWINE FEVER (CSF)

Chapter I in sacrificing every animal of the herd that is sick, in contact and contaminated, and, if neces- DEFINITIONS sary, other herds that have been exposed to the infection, through direct or indirect contact with Art. 1. For the purpose of these Rules: the pathogenic agent, by destroying carcasses, I - Swine farm: places where pigs are raised through incineration or land filling; or kept, regardless of their purpose; XII – Official Veterinary Service: federal, state II - Outbreak: a swine farm or any other or municipal official agency for animal health place with one or more pigs presenting CSF; and inspection; III - Interdiction: forbidden entry or exit of XIII - Pig: any animal belonging to the Sus pigs from a swine farm, regardless of the pur- scrofa (domestic pig) and Sus scrofa scrofa gen- pose, as well as of swine products or byproducts, era (wild pig); or materials that may be a source of transmission XIV – CSF affected pigs: any pig which pres- of the disease, to be decided and defined by the ents officially proved clinical symptoms or lesions Official Veterinary Service. that are compatible with CSF, having its diagnosis IV – Official Laboratory: Laboratory belong- confirmed by laboratory tests; ing to the Ministry of Agriculture, Livestock & XV - Pig under suspicion of CSF infection: Food Supply network; any pig that presents clinical symptoms or CSF V – Slaughterhouse: facility used for the compatible lesions, or yet that its reaction to slaughtering of animals for human consumption, laboratory tests indicates the possibility of ex- or for other purposes, and that are to be submit- isting CSF; ted to official veterinary inspection; XVI – External surveillance zone: the area VI – Accredited Veterinarian: professional around an internal protection zone, defined by accredited by the Official Veterinary Service, as the Official Veterinary Service, at a minimum 10 provided by specific legislation; km ratio from the outbreak; VII – Official veterinarian: professional from XVII – Internal protection zone: area neigh- 347 the Official Veterinary Service; boring an outbreak and which limits are de- VIII – Classical Swine Fever (CSF): transmis- fined by the Official Veterinary Service, based sible disease that attacks pigs and is caused by on geographic and epidemiological factors, at a a pestivirus; minimum 3 km ratio. IX – Contingency Plan: set of emergency XVIII – CSF zone free: zone in which the procedures and decisions to be followed in the inexistence of the disease has been confirmed event of an unexpected outbreak, with the aim of based on the International Animal Health Code controlling and eradicating the CSF agent as fast issued by the World Animal Health Organiza- as possible, thus reducing arising production and tion – OIE. economic losses as much as possible; X - Owner: any person, individual or cor- Chapter II poration that owns, safe-keeps or withholds in custody, or upon any other condition, one or STRATEGIES FOR PROCEDURES TO BE more pigs; UNDERTAKEN XI – Sacrifice and destruction : operation carried out by the Official Veterinary Service when- Art. 2. CSF eradication measures shall be ever a case of CSF is confirmed, and that consists carried out in the zone free, and expanded with the purpose of eradicating the disease from the swine products and byproducts existing in the National Territory. location, until the Official Veterinary Service de- Art. 3. Strategies include, among others, cides on measures to be adopted. implementing the following measures: Paragraph 2. Any infliction to what is set out I – sanitary surveillance; amidst this article shall be duly investigated by II – mandatory and immediate reporting in the Official Veterinary Service, which, if necessary, the event of or suspected presence of CSF; will press criminal charges against the inflictor, to III – immediate assistance to outbreaks; the Federal Attorney, to identify responsibilities. IV – controlling the transit of pigs, its prod- Paragraph 3. In case the inflictor is an accred- ucts and byproducts, animal multiplication ma- ited veterinarian, in addition to what is set out in terial, pathological and biological products that Paragraph 2, the Official Veterinary Service shall may carry the CSF virus, and the facilities that proceed in accordance with what is provided in concentrate pigs; its specific legislation. V – controlling the disinfection of vehicles, equipment, and environments; Chapter IV VI – Sacrifice and destruction of CSF infected or suspected animals, and those they have had WATCH OUT FOR CSF OUTBREAKS contact with; VII – forbidding the use of vaccinations Art. 6. All reporting on CSF suspected cases or against CSF in the entire National Territory, ex- on diseases presenting similar clinical conditions cept in the zones defined by the Animal Health shall be investigated by the official veterinarian, and Inspection Department - DDA; in up to 12 hours maximum after the reporting, VIII – controlling production and supervising and observing biosecurity technical procedures. vaccine trade; Art. 7. Confirmation of a CSF suspicion by a IX – restricting CSF virus handling, except in veterinary in a swine farm will imply in immedi- duly authorized diagnosis or vaccine production ate adoption of sanitary measures to eliminate laboratories. it, as well as to keep it from being spread out to other swine farms, and must always be followed Chapter III by an epidemiological survey in order to determine the origin of the infection. 348 SURVEILLANCE AND INFORMATION Sole Paragraph. The official veterinarian SYSTEM will collect samples from the pigs and send them to the official diagnosis laboratory. Art. 4. The Official Veterinary Service will Art. 8. The swine farm in which a clinical or maintain a zoosanitary surveillance and infor- epidemiological suspicion of CSF has been iden- mation system, at all levels, providing systematic tified will be immediately interdicted by the of- analysis of the data collected, and the production ficial veterinarian. of a periodical bulletin in order to satisfy national Art. 9. If the CSF is officially confirmed by and international commitments. laboratory diagnosis, the Official Veterinary Ser- Art. 5. Every veterinarian, animal owner or vice will define and establish an internal pro- transporter, or any other citizen that is aware of tection zone, up to a minimum ratio of 3 km a suspected case of CSF, or of any other disease around the area of the outbreak, and an exter- presenting a similar clinical condition, is obligat- nal surveillance zone at a minimum 10 km ratio ed to immediately report such fact to the Official from the outbreak. Veterinary Service. Art. 10. The pigs infected with CSF and those Paragraph 1. Whenever facing a suspected they have had contact with will be submitted case of CSF on his land, the owner must imme- to sacrifice and destruction in their respective diately suspend any kind of movement of pigs, swine farm, or in another appropriate location, to be decided by the Official Veterinary Service, of the swine farm will be suspended. in up to 24 hours maximum, starting from the Art. 14. In the Internal Protection Zone, the receipt of the order to slaughter issued by the following measures will be adopted: competent authority. I – census on all farms located within the Art. 11. The following measures shall be zone; taken by the official veterinarian upon the CSF II – forbidden circulation and transportation outbreak: of pigs through public or private routes; I –pigs infected with CSF and those that have III – forbidden transportation of materi- had direct contact with them will be submitted als that may be contaminated, except for those to sacrifice and destruction in their swine farm, that have been cleaned and disinfected, in accor- premises, or any other appropriate location, to dance to the procedures defined by the Official be decided by the Official Veterinary Service, af- Veterinary Service and after the inspection by the ter evaluating them, and in up 24 hours maxi- official veterinarian. mum, starting from the receipt of the order to IV – forbidden entry and exit of animals of slaughter, issued by the Animal Health and In- other species located in the internal protection spection Department - DDA; zone, except if authorized by the Official Veteri- II –pigs that have had indirect contact with nary Service; the animals infected with the CSF agent and that V – forbidden removal of pigs from any farm, are within the same swine farm will be submitted regardless of the purpose, in up to 21 days after to a risk evaluation, and may be sent to sacrifice the conclusion of the preliminary cleaning and and destruction or sanitary slaughtering, which is disinfection operations on the outbreak. Excep- to be decided by the Official Veterinary Service; tion may be made, to be decided by the Official III – destruction of any and every material Veterinary Services, to those animals intended suspected to be contaminated by the CSF virus, for immediate slaughter in state or federally in- including food, excreta, and leachate; spected slaughterhouses. IV – disinfection of facilities, equipment and Paragraph 1. Once the time period referred vehicles belonging to the farm; to in subsection V has elapsed, the Official Veteri- V – sanitary depopulation and introduction nary Service may authorize the removal of pigs of sentinels; from any farm located in the internal protection VI – measures and procedures to eliminate zone, directly to another farm, in the same zone. 349 insects and rodents. Paragraph 2. Those measures adopted with- Sole Paragraph. On farms located at a ratio in the internal protection zone will be carried out of at least 500 m of the outbreak, and after risk and maintained until every existing pig within analysis, the same measures undertaken against the outbreak and all of those they have had con- the outbreak may be adopted, based on judg- tact with, have been submitted to sacrifice and ment and decision to be made by the Official destruction, and all the pigs from all farms lo- Veterinary Service cated in the zone have been submitted to clinical Art. 12. The introduction of sentinel pigs and serological tests. within the outbreak that is being extinct may Art. 15. In the external surveillance zone, only begin 10 days after undertaking clearing and the following measures will be adopted: disinfection measures, as well as after the appli- I – census on all farms located within the cation of other rules foreseen in this Ruling have zone; been concluded. II – forbidden circulation and transportation Art. 13. The swine farm will only be autho- of pigs through public or private routes; rized for repopulation after presenting two nega- III – forbidden transportation of materi- tive outcomes to serological tests, being carried als that may be contaminated, except for those out with an interval of 15 and 30 days respective- that have been cleaned and disinfected, in accor- ly. After this period has elapsed, the interdiction dance to the procedures defined by the Official Veterinary Service and only after inspection by for transportation of the infected pigs, under the official veterinarian. surveillance of the veterinarian responsible IV – forbidden entry and exit of animals of for the slaughterhouse’s sanitary infection, as other species located in the external surveillance provided by the rules set out by the Official zone, except if authorized by the Official Veteri- Veterinary Service. nary Service; Sole Paragraph. The reintroduction of pigs V – forbidden removal of pigs from any farm, intended for slaughter into a slaughterhouse that regardless of the purpose, in up to 10 days after has recorded a case of CSF will only take place af- the conclusion of the preliminary cleaning and ter at least 24 hours have elapsed from the com- disinfection operations on the outbreak. Excep- pletion of cleaning and disinfection operations, tion may be made, to be decided by the Official as set out by subsection IV of this article. Veterinary Services, to those animals intended for immediate slaughter in state or federally inspected slaughterhouses. Chapter V Paragraph 1. Once the time period referred to in subsection V has elapsed, the Official Vet- VACCINATION OF ANIMALS erinary Service may authorize the removal of pigs from any farm located in the internal pro- Art. 17. Vaccination against CSF shall be for- tection zone, directly to another farm, in the bidden in the entire National Territory. same zone. Sole Paragraph. In exceptional situations, Paragraph 2. Those measures adopted with- when clearly demonstrated risk of dissemination in the external surveillance zone will be carried of the disease, after carrying out study on the epi- out and maintained until every existing pig with- demiological situation, and based on judgment in the outbreak and all of those they have had and decision made by the Official Veterinary Ser- contact with, have been submitted to sacrifice vice, emergency use of the vaccine may be autho- and destruction, and all the pigs from all farms rized, through design of a specific plan approved located in the zone have been submitted to clini- by the DDA. cal and serological tests. Art. 16. If ante mortem tests, made at the Chapter VI slaughterhouses, reveal clinical signs that are 350 compatible with CSF, or if lesions compatible with ON THE TRANSIT OF SWINE, PRODUCTS, CSF are found among the animals intended for BYPRODUCTS AND OTHER MATERIAL slaughter, the slaughterhouse’s sanitary inspection service will adopt the following measures: Art. 18. The transit of pigs, its products and I – immediate reporting to the Official Vet- byproducts, animal multiplication material, erinary Service, so it can carry out epidemiologi- pathological and biological products that are pre- cal investigation; sumable carriers and propagators of the disease’s II – immediate slaughtering of all existing virus, will be sustained by regularly issued official pigs in the slaughterhouse, and collection of ma- certification, by the Official Veterinary Service or terial for laboratory diagnosis; accredited veterinarian, as provided in this and III – officially controlled destruction of all other relevant Rules. carcasses and offal in as to prevent CSF propa- Art. 19. The entry or transit, in the CSF gation. Conditional utilization may be permitted, zone free, of live pigs, its products and by- based on risk analysis performed by the Official products, pathological and biological products Veterinary Service. In such case, those products that are presumable carriers and propagators will not be intended for exports; of the disease’s virus, coming from infected IV – washing and disinfecting facilities regions, countries or zones, will only be per- and equipment, including the vehicles used mitted in those situations foreseen in the specific legislation that regulates transit in the CSF Chapter VII zone free. Art. 20. Whenever it is confirmed non-com- GENERAL PROVISIONS pliance to the rules approved for the transit of pigs, its products and byproducts, the Official Art. 22. Whenever CSF is confirmed in Veterinary Service’s competent authority will be slaughterhouses, exhibition sites, fairs, auctions, in charge of hindering the transit and reporting and other pig gatherings, the entire site will be the event. considered an outbreak, and whenever applica- Paragraph 1. If intercepted on the borders ble, the sanitary measures set out in Chapter IV of of the CSF zone free, to order the animals to this Normative Instruction will be adopted. return to their origin, except those infected Art. 23. It is forbidden to use, for pig feed, with the disease, and apply the appropriate rests of food containing protein of animal origin legal sanctions. regardless of where it comes from, except when Paragraph 2. If intercepted within the CSF submitted to thermal treatment to assure inacti- zone free, to order the pig’s apprehension and vation of the CSF virus. slaughter, in addition to applying the appropriate Paragraph 1. CSF virus inactivation as re- legal sanctions. Regarding products and byprod- ferred to in this article takes place at a minimum ucts, they shall be apprehended and destroyed; temperature of 90ºC during 60 minutes, and with and depending on the case and based on judg- continuous agitation. ment made by the competent authority may they Paragraph 2. It is forbidden to keep pigs in be given another destination. waste deposit sites, and to collect and use rests of Art. 21. The vehicles used for the transporta- food from these locations for animal feed. tion of pigs must be washed and disinfected after Art. 24. The disinfection of vehicles and fa- unloading the animals; and the transit of empty cilities as set out in this Normative Instruction and unclean vehicles shall be forbidden, as pro- must be carried out with disinfectants approved vided by the rules in force. and recommended by the Contingency Plan.

NORMATIVE INSTRUCTION SDA No. 19 OF FEBRUARY 15, 2002 351

Published in the Official Gazette of March 01, 2002 Section 1, Page 3

Standards for Accreditation of Swine Breeding Farms

THE SECRETARY OF ANIMAL AND PLANT HEALTH health level in farms that sell, distribute or keep AND INSPECTION – SUBSTITUTE, OF THE BRAZIL- swine breeders for animal breeding purposes, in IAN MINISTER OF AGRICULTURE, LIVESTOCK AND order to prevent the spread of diseases and provide FOOD SUPPLY, proceeding from his attributions desirable levels of productivity, and the contents of established by Article 83, Item IV, of the Internal Process No. 21000.005128/2001-29, decides: Regulation Manual of the Secretariat, approved Art. 1. To approve standards for the accredi- by Ministerial Decree No. 574 of 8 December tation of swine breeding farms, as the APPEN- 1998, pursuant to the Animal Health and Inspec- DIX. tion Regulation, approved by Decree No. 24548, Art. 2. The marketing and distribution within 3 July of 1934, Brazilian territory of pigs intended for breeding, Whereas the economic importance of swine as well as its participation in exhibitions, fairs and farming and the need to maintain an appropriate auctions, shall only be allowed if it comes from Accredited Swine Breeding Farms (ASBF – Granjas farms, from proposals submitted by the Coordi- de Reprodutores Suídeos Certificadas). nation for Surveillance and Health Programs. Sole paragraph. Institutions keeping live- Art. 4. Recommend that Secretaries of Agri- stock for animal breeding purposes shall com- culture and animal health and inspection author- ply with the standards of Accredited Swine ities of the States, to support the development of Breeding Farms . activities under this Normative Instruction. Art. 3. To delegate powers to the Director of Art. 5. This Normative Instruction shall come the Animal Health Department (DSA – Departa- into effect on the date of its publication. mento de Saúde Animal), to publish additional Art. 6. – It is abrogated Normative Instruc- standards for accreditation of swine breeding tion No. 12, 23 June 1999.

RUI EDUARDO SALDANHA VARGAS

APPENDIX

STANDARDS FOR ACCREDITATION OF SWINE BREEDING FARMS

1. DEFINITIONS 1.1.10. Technician in charge: veterinar- 1.1. For the purpose of this Instruction: ian, appointed by the owner, responsible for 1.1.1. Pig: any animal of the gender Sus sp.; compliance with the standards set by this In- 1.1.2. Swine breeder: pigs kept on a farm struction; and used for animal breeding purposes; 1.1.11. Official laboratory: animal labora- 1.1.3. Institutions keeping swine breeding tory belonging to the network of the Ministry of material: central units of artificial insemination Agriculture, Livestock and Food Supply; and disseminators of genes; 1.1.12. Accredited laboratory: laboratory 1.1.4. Breeding farm: establishment or belonging to a public institution that receives, property where pigs are reared or kept for sale by delegation of powers of the Ministry of Ag- 352 or distribution purposes, whose final product is riculture, Livestock and Food Supply, act of ac- intended for breeding; creditation; 1.1.5. Accredited Swine Breeding Farms 1.1.13. Production of breeders: activity (ASBF – Granja de Reprodutores Suídeos Certifi- whose main purpose is producing boars and cada): farm which fully comply with basic and sows; specific standards for accreditation. Farm’s ac- 1.1.14. Full cycle production of breeders: creditation shall be based on serological moni- complete swine breeding farm, involving all stag- toring and health classification pursuant to this es in facilities in the same geographical area; Normative Instruction; 1.1.15. Site 1: producing unit of piglets, in- 1.1.6. Owner: any person or company who volving the stages of insemination, pregnancy, hold under its responsibility pigs whose final maternity, weaning and, depending on the es- product is intended for reproduction; tablishment, nursery and central of insemina- 1.1.7. Official service: federal, state or mu- tion for exclusive use; nicipal animal health body; 1.1.16. Site 2: unit that receives piglets from 1.1.8. Official Veterinarian: veterinarian of Site 1 to foster them at the nursery, nursery and the official service; growth or growth only until the reproduction 1.1.9. Accredited veterinarian: professional ac- phase; credited by the official service in accordance with 1.1.17. Site 3: unit that receives pigs from Site Decree-Law No. 818, dated 5 September 1969; 2 to foster them until the reproduction phase; 1.1.18. Health surveillance: periodic and implement a program of cleaning and disinfec- systematic procedures aimed to test, qualify and tion and vaccination, keeping record of such quantify the level of health in breeding farms for measures and other activities of health control, a specific disease or infection; according to this Instruction, supervised by the 1.1.19. Degree of vulnerability: set of rules official service; aimed to prevent the ingress of pathogens at 2.1.5. The collection of material for labora- breeding farms; tory tests, inoculation of tuberculin and its inter- 1.1.20. Biosafety: Development and imple- pretation for the purpose of health surveillance mentation of strict rules to protect the herd of of farms to be accredited and reaccredited shall swine against the ingress and spread of infec- be performed under direct supervision of the of- tious agents in breeding farms; ficial service, and the cost of examinations shall 1.1.21. Zootechnical data: set of parameters be paid by the owner; of productivity of a breeding farm, intended to 2.1.6. The ingress of pigs for animal replace- characterize and evaluate its performance; ment and breeding material collection in ac- 1.1.22. Quarantine area: a zone aimed credited breeding farm shall only occur if the to keep newly admitted animals, apparently animals come from Accredited Swine Breeding healthy, isolated and under observation, to Farms (ASBF), and accredited at least to the same perform diagnostic tests and prophylactic optional diseases. measures to prevent the ingress of pathogens 2.1.7. Accreditation is valid for six months. It in breeding farms. shall be printed in a specific form by the official 2. BASIC STANDARDS service, based on clinical test results of the herd, 2.1. Swine breeding farms shall comply performed by official or accredited laboratories with the following basic standards, in order to and, in the case of tuberculosis, based on results be accredited: of diagnostic tests performed by the technician 2.1.1. Be registered in the proper body of in charge of the farm and proof of compliance the Ministry of Agriculture, Livestock and Food with other requirements of these Instruction; Supply and keep a record system that allows 2.1.8 Pigs in transit shall be accompanied the identification of animals and their genetic by official transit permit and copy of the ASBF, ancestry. attested by official agent; 2.1.2. Be registered in the official service 2.1.9. Accreditation may be suspended at 353 with jurisdiction in the area, as well as a com- any time by the official service, in case of non- plete animal health record (birth, death, diagno- compliance with this Instruction or upon request sis of diseases, treatments, and vaccination proof the establishment. gram for health monitoring of swine breeders), 3. SPECIFIC STANDARDS with information covering all pigs of the estab- 3.1. Sanitary and biosafety standards that lishment, available to the official service; shall be met by swine breeding farms to be ac- 2.1.3. Adopt biosafety procedures against the credited are: ingress of pathogens and to prevent the spread or 3.1.1. Have a surrounding fence with single exacerbation of diseases in breeding farms; entry and disinfection system for people or ve- 2.1.4. Keep veterinary assistance and a tech- hicles at the entrance; nician in charge, which shall represent the es- 3.1.2. Have loading and unloading station tablishment before the official service, notifying close to the fence; sanitary related events and zootechnical data 3.1.3. Have a guest book, identifying the last through the quarterly technical report submit- date and place of visits to other swine farms, ted to the official service, or immediately in case laboratories, slaughterhouses or other places of diseases of immediate notification. The tech- with the presence of pigs, with a minimum fal- nician shall collect material for laboratory tests, low period of 24 hours; to perform examinations of the herd, and also 3.1.4. Have a disinfection system for the ingress of materials and equipment into the farm; shall comply with all standards for accreditation in 3.1.5. Have wardrobe with impervious walls sites 1 and 3, whereas the site 2 shall only comply and floors, with bath, shower and clothing for with conditions of biosafety, regardless whether the visitors and staff of the breeding farm; the sites are located in the same property or not. 3.1.6. Have known source of water, which 3.1.11. In breeding farms with 2 or 3 sites, is not a natural course, to supply the farm with in case of suspicion of any of the diseases de- tanks protected, cleaned and disinfected at least scribed in this Instruction, in any of the sites every six months; of production, at the discretion of the Ministry 3.1.7. Hold state environmental agency per- of Agriculture, Livestock and Food Supply, tests mission, covering the treatment and disposal of shall be performed at all sites, according to sam- manure; pling standards of this Instruction, even beyond 3.1.8. Have an adequate system, accredited by the date of reaccreditation, and the accredita- the official body, to manage corpses and remains tion of production sites may be suspended until of births (stillbirths, mummified, placentas); the outcome of tests. 3.1.9. Breeding farms with two sites of pro- 3.2. Accredited Swine Breeding Farms , satis- duction shall comply, in both sites, with all stan- fied the items above, shall be evaluated for an dards for accreditation, regardless whether the initial classification to be reviewed annually, sites are located in the same property or not; about their degree of vulnerability to pathogens 3.1.10. Farms with three sites of production ingress, as Table 1.

Tabela 1 – Evaluation of the Degree of Vulnerability of ASBF to the ingress of External Pathogens

Variables Criteria Points Score of the farm 1. Distance to a non-accredited more than 3.5 Km 0 354 swine farm or swine slaughter- 1 - 3.5 Km 1 house. from 500 m to 1 Km 2 less than 500 m 3 2. Density of swine herds in a 1 herd 0 radius of 3.5 Km 2-3 herds 1 4 or more herds 2 3. Farms supplying pigs for herd own replacement or by hysterec- 0 replacement tomy 1 farm 1 2 farms 2 3 or more farms 3 4. Distance from highway where more than 500 m 0 pigs are transported from 300 m to 500 m 1 less than 300 m 2 Variables Criteria Points Score of the farm 5.1. Quality of the isolation of the excellent – double fence 0 farm - fence interspersed with green belt very good – fence screen at least 1 50 m away from sheds good – fence screen less than 50 m 2 away from sheds reasonable – non-screened fence 3 only 5.2. Quality of the isolation of the outside line of the green belt at farm - green belt least 50 m away from farm’s 1 facilities outside line of the green belt less than 50 m away from farm’s 1 facilities no green belt 2 6. Control of visits in the farm occasional visits, with 72h of fallowing. Regime of bath with exchange of clothes and 1 shoes. Bathroom with clean and dirty area. occasional visits, with 48h of fallowing. Regime of bath with exchange of clothes and 1 355 shoes. Bathroom with clean and dirty area. occasional visits, with 24h of fallowing. Regime of bath with exchange of clothes and 2 shoes. Bathroom with clean and dirty area.

7. Existing Quarantine area yes, at least 500 m away from the herd, with green bell; or no 0 external pigs admissions. yes, less than 500 m away from the 1 herd or without green belt.

no quarantine for admitted pigs. 2 Variables Criteria Points Score of the farm 8. Feed given to animals no use of feeding flour of 0 animal origin use of feeding flour of 2 animal origin 9. Source of the feed given to own factory inside the 0 animals establishment third factory 1 10. Transport of feed used in the bulk trucks or vehicles that do not 0 farm carry pigs

the same trucks that carry pigs 2 Farm total score:

3.2.1. Classification of farms in the degree months, by means of ELISA, using kits registered of vulnerability to external pathogens: in the Ministry of Agriculture, Livestock and a) farm “A”: well-protected - from 0 to 5.0 Food Supply, and the sera that tested positive or points, since that has no criteria with a score is suspected shall undergo additional differential 2 or 3; tests, by neutralization tests, including the differ- b) farm “B”: low vulnerability - up to 8.0 entials ones for the Bovine Viral Diarrhoea. points, since that has no criteria with score 3 3.3.4. Breeding farm shall achieve compli- and is not included as farm “A”; ance with CSF only if all tests are negative. In c) farm “C”: moderate vulnerability – from the case of positive test, standard prophylaxis 8.0 to 12.0 points, since that is not included measures for classical swine fever shall be im- 356 as farm “B”; plemented, pursuant to current regulations. d) farm “D”: highly vulnerable - with 13.0 3.3.5. ASBF shall comply with the follow- or more points. ing standards for Aujeszky’s disease: 3.2.2. Evaluating the degree of vulner- 3.3.5.1. Not to perform vaccination of pigs ability of Artificial Insemination Centers (CIA housed in the breeding farm. – Centrais de Inseminação Artificial), Item 3 of 3.3.5.2. Perform serological tests, every the Table 1 shall not be applied. However, all six months by means of ELISA, using kits regis- breeders admitted to CIA shall be tested for tered in the Ministry of Agriculture, Livestock the basic diseases of accreditation. and Food Supply, and the sera that tested pos- 3.3. Health Levels of Accredited Swine itive shall undergo neutralization test; Breeding Farms: 3.3.5.3. Breeding farm shall achieve com- 3.3.1. All Accredited Swine Breeding Farm pliance with serological standards for Aujesz- shall be free from classical swine fever, Aujesz- ky’s disease only if all tests are negative. In the ky’s disease, brucellosis, tuberculosis, scabies case of positive test, accreditation shall be sus- and free or controlled from leptospirosis. pended and serology tests shall be performed 3.3.2. ASBF shall comply with the follow- to 100% of the herd of breeders, with an inter- ing standards for classical swine fever - CSF: val of 30 and 60 days. Remaining positive, the 3.3.3. Perform serological tests, every six farm will lose accreditation. 3.3.6. For brucellosis, serologic tests shall be identification of the mycobacteria involved. performed every six months, using the Rose Ben- 3.3.8. For Leptospirosis, farms shall have gal test or another one approved by the Ministry two options: of Agriculture, Livestock and Food Supply and 3.3.8.1. Breeding farms considered free indicated for the case, and the seroreactive shall from Leptospirosis will be subject to serologic be submitted to additional tests for the 2-mer- control. Serological tests of microagglutina- captoethanol or complement fixation test; tion shall be performed every six months. Sera 3.3.6.1. Breeding farm shall achieve com- shall be tested against the serovars L. canicola, pliance with serologic conditions for brucello- L. grippothyphosa, L. hardjo, L. icterohaemor- sis only if all tests are negative. In the case of rhagiae, L. pomona and L. bratislava, showing positive test, accreditation shall be suspended. negative results. Positive tests shall be eliminated and the herd 3.3.8.2. At the discretion of the sanitary au- completely retested within 30 days. Remaining thority, additional serovars may be included. positive, the farm will lose accreditation. 3.3.8.3. Breeding farms considered con- 3.3.7. For tuberculosis, male and female trolled for Leptospirosis (with vaccination), the breeders shall be tested, by sampling, as the accreditation shall contain the words “farm vac- table of Item 3.3.11.1, every 6 (six) months cinated for Leptospirosis”. The vaccine shall con- in the comparative test with bovine PPD and tain all serovars contained in Section 3.3.8.1. avian PPD tuberculin. 3.3.9. For scabies, two tests of scraping 3.3.7.1. The reading shall occur after 48 of the skin shall be performed, every 2 or 3 hours, using millimetric ruler, measuring the months, including 5 breeders and 5 pigs for largest diameter of the reaction. The interpre- slaughter, identified by the official veterinar- tation of the test will be based on the herd, ian, using clinical examination as potential whereas the arithmetic mean of reactions carriers of scabies. Everyone shall present greater than 0.5 cm. negative results. 3.3.7.2. The farm shall achieve compli- 3.3.9.1. If positive, accreditation shall be ance with standards for tuberculosis if all ani- suspended and eradication performed through mals are negative for bovine PPD or in case drug treatment, developed and implemented of a positive reaction, the average diameter of by the technician in charge. reactions to bovine PPD is lower than the aver- 3.3.10. Farms that do not fully comply 357 age diameter of PPD reactions to influenza. with standards mentioned in this Instruction 3.3.7.3. The farm shall be considered posi- shall lose the condition of Accredited Swine tive for tuberculosis if the average diameter of Breeding Farms (ASBF). reactions to bovine PPD is greater than the 3.3.11. Farms will be accredited after the mean diameter of avian PPD reactions. In this completion of two consecutive negative tests case, accreditation shall be suspended and at intervals of two to three months for all dis- sanitation measures implemented. eases described in this Instruction, except for 3.3.7.4. If the average diameter of tuber- scabies. In this particular case, it will be ac- culin reactions to avian PPD is higher than the cording to item 3.3.9. average of the reactions to bovine tuberculin 3.3.11.1. In the first test, 100% of the PPD, the farm shall be considered infected with breeder herd shall be tested. Table 2 shall be Mycobacterium Avium Complex (MAC). In this used in the sampling for the second test and case, the farm does not lose accreditation and subsequent monitoring. In the case of new a program of control shall be implemented. farms, populated with the surveillance of the 3.3.7.5. In case of suspicious interpreta- official service, with animals proceeding from tion of reactions to tuberculin, the farm shall already accredited farms, there shall be no temporarily lose accreditation, until diagnosis need for testing 100% of the herd. In this case, is completed, based on laboratory testing for prescriptions of Table 2 are enough. Table 2 - Sampling of Accredited Swine Breeding Farms (ASBF). Number of animals for blood collection and completion of comparative tuberculin test, according to the number of swine breeders in the herd, considering an estimated prevalence at 5% and a confidence level of 95%.

Nº. of breeders in Nº. of animals to nº. of breeders in Nº. of animals to the herd be sampled the herd be sampled

10 10 350 54

20 19 400 55

30 25 450 55

40 31 500 56

50 35 600 56

60 38 700 57

70 40 800 57

80 42 900 57

90 43 1000 57

100 45 1200 57

120 47 1400 58

140 48 1600 58 358 160 49 1800 58

180 50 2000 58

200 51 3000 58

250 53 4000 58

300 54 > 5000 59

4. DISEASES FOR OPTIONAL ACCREDITA- eases listed below: TION 4.1. Progressive Atrophic Rhinitis (PAR): At the discretion of the owner of the breed- 4.1.1. Breeding farm shall be considered ing farm, the Ministry of Agriculture, Livestock free from PAR if: and Food Supply, from June 2002 on, can issue - No Toxigenic type D Pasteurella multocida optional accreditation free from any of the dis- is detected in 3 starting consecutive tests with an interval of 30 days. It shall be collected nasal 4.3. Porcine Pleuropneumonia and tonsil swabs of 30 piglets with 8 weeks of 4.3.1. Breeding farm shall be considered age that are not being treated with antibiotics. free from Porcine Pleuropneumonia if: The swabs shall be placed in a transport medi- - No pathogenic serovars of Actinobacil- um (0.5 ml) and kept at 4 Celsius degrees. In the lus pleuropneumoniae is detected in 3 starting laboratory, the swabs shall be cultured on selec- consecutive tests, with an interval of 30 days, tive medium Agar 8HPG, blood agar and placed by the polyvalent ELISA test on 30 piglets with back in the transport medium. Then it is shaken 13 or more weeks of age. If damages caused by in vortex, and with the suspensions obtained, a Porcine Pleuropneumonia are detected at the pool of five animals is selected (0.10 ml x 5> 0.50 slaughterhouse, secretions and fragments of ml), which shall be inoculated in mice. After 7 tonsil shall be collected from positive animals days, the mice will be sacrificed, an attempt to and submitted to direct bacteriological tests in isolate P. multocida. Samples of P. multocida will selective medium, applying the immunomag- be tested to identify their toxigenicity by ELISA, netic separation for isolation of Actinobacillus Seroneutralization Assay or PCR. pleuropneumonia, or PCR test. - No damage is found in nasal turbinate - No damages caused by Porcine Pleuro- superior than 1 by the method of visual assess- pneumonia is detected in 3 starting consecu- ment (the scale is 0> no lesion, 1> slight de- tive tests with an interval of at least 30 days, 30 viation from normality; 2> moderate damaged piglets aged 5 to 6 months. If any damage con- and 3> serious damaged), 3 starting consecutive sistent with PPS is observed, it shall be used in tests, with an interval of 30 days. Tests shall be serotyping test and to perform tests intended to performed in a group of at least 30 pigs aged five isolate Actinobacillus pleuropneumoniae. to six months. 4.3.2. To remain accredited, tests shall be 4.1.2. To maintain the accreditation, tests repeated, once, every 6 months, with all results shall be repeated every 6 months, all with nega- negative. tive results. 4.4. Swine Dysentery (SD) 4.2. Mycoplasma pneumonia (MP) 4.4.1. Breeding farm shall be considered 4.2.1. Breeding farm shall be considered free from SD if: free from Enzootic Pneumonia if: - Brachyspira hyodysenteriae is not de- - Mycoplasma hyopneumoniae is not detected tected in 3 starting consecutive tests with an 359 in 3 starting consecutive serological tests, with an interval of 30 days, by laboratory tests of a interval of 30 days, 30 pigs aged over 10 weeks. If pool of feces from 6 pigs per pen, taken from there is positive serology and absence of damage 6 different pens of pigs on growth. The feces at slaughter, live animals with positive serology shall be tested by direct immunofluorescence shall be submitted to bronchial washing and col- and confirmed by PCR. To remain accredited lection of material for Nested-PCR and/or cultiva- tests shall be performed every six months, of a tion of Mycoplasma hyopneumoniae. pool of feces from 6 pigs, from 6 different pens - No pulmonary damage caused by MP of pigs on growth. is found in 3 starting consecutive tests at the 4.4.2. To remain accredited, tests shall be slaughterhouse, with an interval of 30 days, 30 repeated, once, every 6 months, with all results piglets aged 5 to 6 months. If damages caused negative. by MP are found, they shall be submitted to 4.5. Concerning diseases described in items histopathology, followed by immunofluores- 4.1, 4.2, 4.3, 4.4, the ASBF shall be classified into cence or immunoperoxidase test for Mycoplas- four levels, as follow: ma hyopneumoniae. a) Level 1: free from four optional diseases; 4.2.2. To remain accredited these tests shall b) Level 2: free from at least two optional be repeated, once, every 6 months, all with neg- diseases; ative results. c) Level 3: free from one optional disease; d) Level 4: no accredited for optional diseases. struction are described in the legislation of 5. FINAL DECISIONS Animal Health , regardless of the loss of ac- 5.1. At the discretion of the Animal Health creditation. and Inspection Department additional diseases 5.3. Cases not covered by this Normative can be required for accreditation. Instruction shall be addressed by the Animal 5.2. Penalties resulting from non-com- Health and Inspection Department. pliance with standards of this Normative In- (Of. El. No. OF-SDA019-02)

CCOMPLEMENTARY LEGISLATION

NORMATIVE INSTRUCTION No. 1 OF JANUARY 4, 2001

Published in the Official Gazette of January 22, 2001 Section 1, Page 11

Approves Norms for the admission of pigs, their products and subproducts in the Zone Free of Classical Swine Fever, consisting of the States referred to therein.

NORMATIVE INSTRUCTION No. 1 OF JANUARY 4, 2001

Published in the Official Gazette of January 16, 2001 Section 1, Page 6 (Modified by IN No 7 of February 27, 2009)

Declares the region consistent of the States of Rio Grande do Sul, Santa Catarina, Paraná, São Paulo, Minas Gerais, Mato Grosso do Sul, Mato Grosso, Goiás, Tocantins, Rio de Janeiro, 360 Espírito Santo, Bahia, Sergipe, Rondônia and the Federal District as a classical swine fever free zone. part III Animal Movement and Quarantine Control

ADMINISTRATIVE RULING No. 162 OF OCTOBER 18, 1994

Published in the Official Gazette of October 21, 1994 Section 1, Page 15934 Altered by Normative Instruction No. 44 of October 02, 2007

Approves complementary Norms attached to this Administrative Ruling, issued by the Animal Health and Inspection Department, which deal with Inspection and Animal Health Control in Exhibitions, Agricultural Fairs, Auctions and other livestock agglomerations, throughout the national territory.

THE SECRETARY OF ANIMAL AND PLANT tached to this Administrative Ruling, issued by HEALTH AND INSPECTION, through the jurisdic- the Animal Health and Inspection Department, tion conferred to him by Article 78, item VI, of the which deal with Inspection and Animal Health Internal Rules of the Secretariat, approved by Min- Control in Exhibitions, Agricultural Fairs, Auctions isterial Administrative Ruling No. 212, August 21, and other livestock agglomerations, throughout 1992, and taking into consideration that contained the national territory. within Article 2 of the Ministerial Administrative Art. 2. This Administrative Ruling shall come Ruling No. 108 of March 17, 1993, resolves: into effect on the date of its publication, revoking Art. 1. Approve complementary Norms at- all contrary provisions.

TÂNIA MARIA DE PAULA LYRA 361

ANNEX

COMPLEMENTARY NORMS TO THE MINISTERIAL ADMINISTRATIVE RULING No. 108, OF MARCH 17, 1993, ABOUT INSPECTION AND ANIMAL HEALTH CONTROL IN EXHIBITIONS, FAIRS, AUCTIONS AND OTHER LIVESTOCK AGGLOMERATIONS, THROUGHOUT THE NATIONAL TERRITORY

CHAPTER I national or state level animal health and inspection body, as provided for in Article 6 of Admin- ABOUT PRIOR AUTHORIZATION FOR istrative Ruling No. 108 of 17 March 1993, of the EXHIBITIONS, AGRICULTURAL FAIRS, Minister of State of Agriculture, Food Supply and AUCTIONS AND OTHER LIVESTOCK Agrarian Reform. AGGLOMERATIONS. Paragraph 1. For exhibitions and fairs of interstate, national or international jurisdic- Art. 1. The holding of fairs and exhibitions tion, prior authorization from the Federal of livestock shall be previously authorized by the Board of Agriculture, Food Supply and Agrar- ian Reform in the States will be also required. II – in the case of exhibitions and fairs, the Paragraph 2. The authorization must be indication of the veterinarians of the Animal sought in the following terms: Health and Inspection Committee; a) – 30 days in advance for events of munici- III – in the case of actions, the indication of pal and regional jurisdiction; the veterinarian responsible for animal care; b) – 60 days in advance for events of state, IV – Deadline for the entry of animals in the interstate and national jurisdiction; enclosure of the event. c) – 90 days in advance for events of international jurisdiction. CHAPTER III Art. 2. The completion of auctions depends on prior authorization of the veterinary author- ABOUT THE FACILITIES ity of the city, except those involving only animals raised in the establishment where it will be held. Art. 6. The holding of exhibitions, fairs and Art. 3. The request for authorization to con- auctions of livestock shall only be permitted in duct the auction must be done to animals, en- places that have the following facilities: closing statement of technical responsibility in I – place for reception of animals, with the the case of private professional, signed by him landing pad, restrainer and pens; and by the sponsor of the event, with at least II – place for government services and ani- three (3) working days in advance, including: mal health and inspection; I – Place and date; III – site for housing of animals; II – Number of animals per species, gender IV – location for isolation of sick animals; and age; V – track for animal judgment; III – Source of animals (city and state); VI – pediluvium (foot bath) and road bath on IV – The name of the veterinarian, private or all accesses to the park; official, responsible for veterinary care for animals, VII – water and electricity supply; enclosing statement of technical responsibility in VIII – toilets for visitors and staff team; the case of private professional, signed by him. IX – ration warehouse. Sole paragraph. for the auctions, the facilities CHAPTER II listed in items IV, V and IX will not be required. Art. 7. The facilities where the animals move 362 ABOUT THE INTERNAL RULES OF and remain, including the floors should be con- EXHIBITIONS, FAIRS AND AUCTIONS structed of resistant materials which allow their OF LIVESTOCK. complete cleaning and disinfection. Art. 8. The facilities for which the animals Art.4. The promoters of exhibitions, fairs have moved or remained must be washed and and auctions of livestock must prepare internal disinfected after leaving them at least twenty- rules of the event, with the required prior, to be four (24) hours before the entry of new batch of distributed to exhibitors (farmers) at the event by animals, in a satisfactory way for the local veteri- the time of their application. nary authority. Art. 5. The internal rules of the event, pro- Sole paragraph. in the case of auction places vided for in Article 7 of Ministerial Administra- without cement floor, all manure must be removed tive Ruling No. 108, of March 17, 1993, must and possibly used materials (sawdust, etc.) before include, among others: the entry of new batch of animals, being applied an I – general and specific sanitary require- appropriated disinfectant to the floor and facilities, ments – tests for diagnosis of diseases, vacci- in a satisfactory way for the veterinary authority. nations and treatment, required for admission Art. 9. To disinfect the facilities, it may be of animals in the enclosure of the fair, accord- used, among others, sodium carbonate (4%), so- ing to species and purpose; dium hydroxide (2%) and oxide lime (5%). CHAPTER IV months or older, except for cattle and buffaloes for cow calf, rearing or fattening, whose final des- SANITARY REQUIREMENTS FOR ISSUANCE tination is slaughter, or for immediate slaughter. OF ANIMAL MOVEMENT PERMIT, FOR ANIMALS INTENDED FOR EXHIBITIONS, Section III FAIRS AND AUCTIONS. Minimum Requirements for equidae Art. 12. In the issuance of the Animal Move- Section I ment Permit (GTA) for equidae, for participation General Requirements of animals in exhibitions, fairs and auctions, the Art. 10. In the issuance of the Animal Move- following requirements must be fulfilled: ment Permit (GTA), for participation of animals I - for equine infectious anaemia (EIA), nega- in exhibitions, fairs and auctions, the following tive laboratory test, performed in the following requirements must be fulfilled: periods, counted before the event: I - animals must be in good health without a) up to 180 days, for equid coming from signs of disease and free of external parasites; controlled entities; II - animals must come from establishment b) up to 60 days, in other cases. where, within 60 days prior to the date of issue of II - vaccination against equine influenza authorization, there was no occurrence of clinical (type A) performed from the minimum of fifteen disease for which the species is susceptible; (15) days and a maximum of one hundred eighty III - animals must be identified in accordance (180) days before the start of the event, when ap- with the standards established by this Comple- propriate, according to the epidemiological situ- mentary Norms. ation of the disease.

Section II Section IV Minimum Requirements for cattle Minimum Requirements for pigs and buffaloes Art. 13. In the issuance of the Animal Move- Art. 11. In the issuance of the Animal Move- ment Permit (GTA) for pigs, for participation of ment Permit (GTA) for cattle and buffaloes, for par- animals in exhibitions, fairs and auctions, the ticipation of animals in exhibitions, fairs and auc- following requirements must be fulfilled: I - for classical swine fever (CSF): tions, the following requirements must be fulfilled: 363 I – revoked a) in exhibitions, fairs and auctions con- II – for bovine brucellosis (B. abortus) ducted in the regions controlled, where vaccina- a) Negative serum-agglutination test, carried tion against CSF is not allowed, pigs must come out up to 60 days before the event, except for from region with same sanitary status and from male cattle and buffaloes for cow calf, rearing or establishment where there is no record of the CSF fattening, castrated or not, whose final destina- within 180 days preceding the date of event; tion is slaughter, or for immediate slaughter; b) in exhibitions, fairs and auctions con- b) In the case of female with up to 30 months ducted in regions where vaccination against CSF old, vaccinated between 3 and 8 months of age is permitted, the pigs must come from establish- with B-19 vaccine, the laboratory test may be re- ments where there is no record of the CSF within placed by a certificate of vaccination; 180 days preceding the date of commencement c) The test referred to in the item may be of the event and must demonstrate the CSF vac- waived for general herd cattle (registered or con- cination done up to 180 days before the event; trolled), for participation in auctions, at the dis- II - for FMD, the animals must come from es- cretion of the state veterinary authorities. tablishment where, within 60 days prior to the start III - for bovine tuberculosis, intra-dermal of the event, there has been found no case of FMD, inoculation carried out up to 60 days before the as well as in the neighborhood in the last 30 days; event, for cattle and buffaloes with twelve (12) III – for brucellosis, tuberculosis, Aujeszky’s disease, the breeding male and female, must ment Permit (GTA) for domestic birds, for participa- come from herds officially free of these diseases, tion of animals in exhibitions, fairs and auctions, bought by official certificate issued by the compe- the following requirements must be fulfilled: tent veterinary authority of the place of origin. I - for pullorum disease, negative laboratory test performed up to sixty (60) days before the Section V date of event, for growing birds or already adults; Specific Requirements for goats II - vaccination against Newcastle disease, Art. 14. When issuing GTA for goats, for par- according to the age of the bird. ticipation in exhibitions, fairs, auctions and other animals aglomerations, should be observed the Section VII following requirements: Specific Requirements for Lagomorphs I - for FMD, coming from establishment Art. 17. In the issuance of authorization for where, within 60 days prior to the start of the transit of rabbits, for participation in exhibitions, event, no case of FMD has been found, as well as fairs, auctions and other livestock agglomerations, in the neighborhood within the last 30 days; the establishment of origin must have had no re- II-to caprine arthritis encephalitis (CAE): cord of myxomatosis in one hundred eighty (180) a) - breeding males and females, with more than days prior the starting date of the event. one year of age should present negative results on the agar gel immunodiffusion test for the diagnosis Section VIII of CAE, conducted one hundred and eighty (180) days Other Requirements before the event;-orb) - at the discretion of the state Art. 18. The GTA, the attestations or certifi- veterinary authorities, IF is not possible to proceed cates of laboratory tests, allergy tests and vacci- the laboratory test, the goats must be obtained from nations must accompany the animals and shall a herd where there has been no demonstration of be submitted to the CDSA or the veterinarian CAE clinical sings eighty (180) days prior to the event. responsible for entering the facilities of exhibitions, fairs and auctions. Section VI Art. 19. At the discretion of the state vet- Specific Requirements for sheep erinary authorities and taking into consideration Art. 15. In the issuance of the Animal Move- the epidemiological situation of the state or re- ment Permit (GTA) for goats, for participation of gion where the event takes place, other sanitary 364 animals in exhibitions, fairs and auctions, the fol- requirements might be complied with, including lowing requirements must be fulfilled: tests for diagnosis of diseases and vaccinations, I – for FMD, coming from establishment for participation of animals in exhibitions, fairs, where, within 60 days prior to the start of the auctions or other agglomerations. event, no case of FMD has been found, as well as in the neighborhood within the last 30 days; CHAPTER V II – for brucellosis (B. ovis): a) breeding males should give negative re- ADMISSION OF ANIMALS IN THE sults of the agar gel immunodiffusion test, con- FACILITIES OF EXHIBITIONS, FAIRS ducted up to sixty (6) days before the event; AND AUCTIONS b) at the discretion of the state veterinary authorities, when the laboratory test cannot be Art. 20. All animals must be examined by performed, clinical examination for detailed veri- a veterinarian, in an appropriate place, before fication of ovine epididymitis. his admission to the venue of the exhibition, fair or auction, being only allowed the entry of Section VI animals: Specific Requirements for Domestic birds I – identified, individually or in the lot, accord- Art. 16. In the issuance of the Animal Move- ing to the provisions in this Complementary Norms; II – accompanied by sanitary documenta- in Articles 24 and 25 shall be identified according tion regularly issued in the place of origin, iden- to the adopted for the species. tifying the animals and assuring compliance with general and specific sanitary requirements, CHAPTER VII according to the species; III – declared healthy and free from ectopar- ABOUT VETERINARY CARE asites, after sanitary inspection. Art. 21. The entry of animals affected or Art. 26. Veterinary care during the events suspected of contagious disease, animals re- shall be carried out: agents for laboratory or allergic tests required I – by a Committee of Animal Health and In- as well as animals which carry ectoparasites spection (CDSA), previously known, which must shall not be allowed in the venue of exhibi- include at least one official veterinarian of the tions, fairs and auctions and other agglom- animal health and inspection body, in the exhi- erations. bitions and fairs of any category; Sole paragraph. In the case of contagious II - in auctions, by a veterinarian, official or disease, the prohibition of entry is extended to independent, previously appointed or hired by the susceptible animals that had contact with the promoters of the event. sick animals. Art. 27. It behooves the CDSA and the veteri- Art. 22. The animals whose entrance in the narian mentioned in item II of Article 26 to: venue of the exhibition, fair or auction has not I - ensure that the facilities have been been allowed shall return immediately to the es- cleaned and disinfected at least twenty-four (24) tablishment of origin. hours before the entry of animals; Sole paragraph. In the case of animals af- II - make a health inspection of animals be- fected or suspected of contagious disease, at the fore they enter the precincts of the event; discretion of the veterinary authority, they shall III - check the sanitary documentation that be kept isolated in appropriated place, with ad- accompanies the animal and the compliance ditional measures provided in the relevant fed- with general and specific requirements, accord- eral and state legislation. ing to animal species and purpose; IV - provide medical attention to animals CHAPTER VI that need, if the owner does not have the vet- 365 erinarian; ANIMAL IDENTIFICATION V - authorize the use of medication in animals; Art. 23. The cattle, buffaloes, pigs, sheep, VI - authorize the removal of the animals goats and rabbits, must be individually identi- in the enclosure of the fair, making the health fied by a permanent number placed the fire, tat- inspection and issuing the appropriate sanitary too or other approved. documentation. Sole paragraph. The cattle, buffaloes, pigs, Art. 28. The occurrence or suspicion of any sheep goats and rabbits, for breeding, whose fi- disease in animals during the fair shall be im- nal destination is slaughter, or intended for immediately communicated to the CDSA or the mediate slaughter may be identified by lot, with veterinarian responsible for adoption of neces- a fire mark of the breeder or other, according to sary measures according to the nature of the the establishment or herd of origin. occurrence. Art. 24. Horses must be accompanied by Art. 29. In case of occurrence or suspicion a passport, attestation or certificate regularly of contagious disease during the event, the issued by competent authority that contains veterinary authority shall isolate the sick or graphic individual review. suspects animals, in an appropriate place and Art. 25. Animals of species not mentioned decide to ban the facilities and surrounding areas, adopting other measures deemed neces- CHAPTER VIII sary and provided in the relevant federal and state legislation. ABOUT THE PARTICIPATION OF ANIMALS Art. 30. The ban mentioned in the previ- FROM OTHER COUNTRIES ous article may cover the whole floor or part of the event, including surrounding areas where Art. 33. The participation of animals from animals remain susceptible to the disease sus- other countries in exhibitions, fairs and auctions, pected or diagnosed, preventing the movement regularly imported under the current rules, will of available animals at time required, at the be allowed if they comply with the general and discretion of the local veterinary authority. specific sanitary requirements provided for in Art. 31. In the event of non-contagious this Complementary Norms and other to be es- disease, treatment of the animal may be con- tablished according to the country of origin. ducted under the responsibility of the owner’s Art. 34. To be admitted to the venue of exhi- veterinarian, with prior consent of the CDSA or bitions, fairs and auctions, the animals from other the veterinarian responsible. countries must have entered into the national terri- Art. 32. At the end of the exhibition, fair or tory for at least fifteen (15) days, for species suscep- auction, the CDSA or veterinarian responsible, tible to foot and mouth disease and seven (7) days shall present to the animal health and inspec- to the other species, kept under observation in an tion organ a summary report, containing: appropriate place until the beginning of the event, I – number of animals per species, gender, being forbidden the admission to the venue of the age and origin (city and state); event of animals coming directly from outside. II – destination of animals traded or not, Sole paragraph. the matter provided under the indicating the establishment, city and state, per “caput” of this Article shall not apply to animals taken species; directly from exhibitions held in one of the countries III – sanitary occurrences verified during members of MERCOSUR, with animal health docu- the event, with the adopted measures; ments issued by official veterinarian of the country of IV – copy of sanitary attestations or certifi- origin, complying with the standards set specifically cates received and issued. for transit between official exhibitions. HAMILTON RICARDO FARIAS 366 NORMATIVE INSTRUCTION Nº. 46 OF SEPTEMBER 2, 2008

Published in the Official Gazette of September 03, 2008 Section 1, Page 3

Approves procedures for importation of genetic material intended for the restitution of poultry stocks of chickens (Gallus gallus), guinea fowl (Numida meleagris), turkeys (Meleagris gallopavo), quails (Coturnix coturnix), palmiped birds (ducks, gooses and widgeons), pheasants (Phasianus colchicus) and partridges (genus Alectoris)

THE STATE MINISTER OF AGRICULTURE, tion, approved by Decree No. 24.548 of July LIVESTOCK AND FOOD SUPPLY, using the pow- 3, 1934 and what is contained in Process No. ers invested in him under art. 87, sole para- 21000.004645/2007-76, resolves: graph, item II of the Constitution, in consid- Art. 1. To approve procedures for impor- eration of what is provided for by Decree No. tation of genetic material intended for the 5.741 of March 30, 2006, in the Regulation restitution of poultry stocks of chickens (Gal- of the Animal Sanitary Health and Inspec- lus gallus), guinea fowl (Numida meleagris), turkeys (Meleagris gallopavo), quails (Coturnix arise from the application of this Normative coturnix), palmiped birds (ducks, gooses and Instruction will be handled by the Animal and widgeons), pheasants (Phasianus colchicus) Plant Health and Inspection Secretariat. and partridges (genus Alectoris) described in Art. 3. This Normative Instruction comes Annex I, and the zoosanitary requirements for into force one hundred and eighty (180) days the importation of hatchable eggs and day- after its publication. old birds, included in Annexes II and III. Art. 4. Normative Instruction No. 14, June Art. 2. Obscure cases and doubts that may 29, 1999 is hereby revoked.

REINHOLD STEPHANES

ANNEX I

ON THE PROCEDURES FOR IMPORTATION OF GENETIC MATERIAL INTENDED FOR THE RESTITUTION OF POULTRY STOCKS OF CHICKENS, GUINEA FOWL, TURKEYS, QUAILS, DUCKS, GOOSES, WIDGEONS, PHEASANTS AND PARTRIDGES

Art. 1. The importation of bird genetic for exportation, certified by the veterinary- ser material for restitution of the national poultry vice of the country of origin; stock will occur in the form of hatchable eggs Sole Paragraph. Further information may and day-old birds. be required by MAPA, as a means of assessing Art. 2. The importation of genetic material the sanitary risk involved in the process of im- intended for the restitution of poultry stocks of portation of the genetic material. chickens, guinea fowls, turkeys, quails, ducks, Art. 4. To authorize the importation of ge- gooses, widgeons, pheasants and partridges will netic material from qualified establishments from only be allowed from countries licensed by the the country of origin, the Animal Health Depart- Brazilian Ministry of Agriculture, Livestock and ment – DSA may assign technicians to carry out Food Supply – MAPA, and from breeding facili- visits to the establishment, with the intention of ties licensed by the Official Veterinary Service of assessing the sanitary control programs, and veri- the exporting country and by MAPA. fying the information submitted by the Official Sole Paragraph. The term genetic material in- Veterinary Service of the exporting country. 367 tended for the restitution of poultry stocks comprises Sole Paragraph. To authorize the importa- hatchable eggs and day-old birds, where hatchable tion of avian genetic material from producing eggs are those intended for incubation, and day-old establishments, the Animal Health Department birds are those whose age is not over seventy two will observe whether the monitoring program of (72) hours after cracking and that have not had ac- the breeding farm meets the certification rules of cess to any external source of food or water. MAPA’s National Program for Avian Health, and if Art. 3. The veterinary service of the export- it works under the standards described in the San- ing country must submit the following informa- itary Safety and Hygiene Procedures set forth by tion to MAPA before Brazil authorizes the impor- the World Organization for Animal Health – OIE. tation of genetic material: Art. 5. The import authorization must be I – name and full address of the licensed es- specific to each exporting company and ship- tablishment in the country of origin; ping location, and an International Zoosanitary II – annual production capacity of the li- Certificate – CZI must be issued for each estab- censed establishment in the country of origin; lishment of origin. and Art. 6. The authorization to import genetic III – description of sanitary control programs material will be issued by MAPA for owners of es- carried out in the rearing establishment licensed tablishments registered in the Federal Agriculture Superintendences – SFA, as set forth by Normative ported genetic material upon its arrival will be Instruction No. 56, of December 4, 2007, and for performed by a Agriculture Livestock Federal In- avicultural establishments receiving genetic mate- spector – FFA, who will draw a Collection Record rial which are certified by the sanitary programs of for biologic sample material in three copies (1st the National Program for Avian Health - PNSA copy - laboratory, 2nd copy - importer, 3rd copy Paragraph 1. Those interested in importing - issuing record). avian genetic material for breeding must obtain Art. 11. The imported genetic material will be a previous authorization (Import Authorization) submitted to sample collection for the execution of from the Animal and Plant Health and Inspec- laboratory tests, during the clearance process for tion Service – SEDESA of the SFA in the Federa- entry into the country. The samples will be sent to tion Unit where the avicultural establishment the official laboratory in sealed packages. receiving the imported product is located. Paragraph 1. In the case of hatchable eggs, Paragraph 2. Those interested in importing samples will consist of thirty (30) specimens col- avian genetic material for breeding must submit lected from the imported batch, originating from their ordinary monthly import schedule for the the same grange of origin. forthcoming month to the Avian Health Coordina- Paragraph 2. In the case of day-old birds, all tion – CSA of the DSA and to SEDESA / SFA up to dead birds must be collected, and twenty living the 5th day of the previous month, either directly specimens must be slaughtered per grange of or through agencies representing their class. origin for collection of blood, swabs and organs, Paragraph 3. SEDESA / SFA must be notified according to the following list: of the arrival confirmation of each imported I – pool of 20 tracheal swabs; batch at least twenty (20) days prior to arrival II – pool of 20 cloacal swabs; of the cargo, with confirmation of date, place III – pool of 20 air sac swabs in Frey broth; and time, thus allowing the official laboratory to IV – pool of 20 liver, vesicle and spleen schedule it activities. swabs; Art. 7. Entry points of the genetic material V – pool of 20 yolk swabs; into the Brazilian Territory will be VI – pool of 20 caecum swabs; the International Airport of Viracopos – VII – bottom of box swab in peptonated so- Campinas / SP, and the International Airport of lution, tamponated at 1%; São Paulo – Guarulhos / SP. VIII – 20 tracheas; and 368 Sole Paragraph. Authorizations for entry of IX – 20 bottles containing 2 ml of individual genetic material from other locations will be is- serum from the sampled birds. sued at DSA/SDA/MAPA’s discretion. Paragraph 3. The collected samples must be Art. 8. The importer of genetic material will properly identified, sealed and immediately sent be the depository of the goods during the quaran- to the official laboratory for execution of the re- tine period, regarding the publication of the results quired tests. of monitoring activities carried out for the diseases Paragraph 4. The following tests will be car- mentioned in this Normative Instruction, and will ried out: serological and bacteriological research only be allowed to move the birds within the coun- for Salmonella pullorum, S. gallinarum, S. typh- try after receiving an authorization issued by MAPA. imurium, S. enteritidis, Mycoplasma synoviae, M. Art. 9. The genetic material must be manda- gallisepticum, M. meleagridis (turkeys) and sero- torily transported along with a CZI from the mo- logical and virological research for the Newcastle ment of its departure from the country of origin. disease and avian influenza viruses. Sole Paragraph. The CZI must be issued by Paragraph 5. Additional tests may be re- the Official Veterinary Service of the exporting quired by the DSA at any given time, in the event country, and written in the official language of of a change in the epidemiological and sanitary the country of origin and in Portuguese version. status of the exporting country. Art. 10. The sanitary inspection of the im- Art. 12. During the quarantine period, in the event of a suspected occurrence of an offi- miological investigation procedure to assess any cially controlled disease in the batch of imported possible risks to the national poultry stock. genetic material, the SEDESA / SFA of the Federa- Art. 14. Hatchable eggs must be identified, tion Unit where the importing establishment is incubated and hatched in exclusive machines. located will postpone the quarantine period of Birth must occur on a date distinct from the oth- the holding until the final results of the laborato- er batches, and must be notified to the SEDESA of ry tests are issued. The importer must notify the the SFA of the Federation Unit where the hatch- official service about the identification of clinical ery is located. Birth and transfer dates must be signs of officially controlled diseases. notified to the avicultural establishment of desti- Art. 13 .Test results must be issued in proper nation, at least fifteen (15) days in advance. forms and published according to the defined Art. 15. Clearance for birds born in the Na- flowchart: tional Territory, product of imported hatchable I – negative result: LANAGRO must imme- eggs, is subject to negative results of laboratory diately send an official notification to the CSA / tests performed by the official collection service. DSA and to the SEDESA / SFA of the Federation Art. 16. On the day of birth of chicks origi- Unit where the importing poultry establishment nating from imported eggs, an official material is located. SEDESA will determine the end of the collection will be performed for analysis of the quarantine period; or diseases listed in the PNSA. II – positive result: LANAGRO must imme- Paragraph 1. Sampling of these tests will diately send an official report to the CSA / DSA, follow the same procedure for birds born from which will forward it to the SEDESA / SFA of the fertile eggs produced in National Territory. These Federation Unit where the importing avicultural tests can be performed in laboratories approved establishment is located. SEDESA will notify the by the General-Coordination for Laboratory Sup- importer of the results and supervise the execu- port – CGAL for this purpose, and this General- tion of measures necessary for the elimination Coordination will comprise tests performed in of sanitary risks for the national poultry stock. pecked eggs, meconium, trachea and drag swabs Paragraph 1. In the event of a positive re- from the chicks birth room. sult in hatchable eggs for Newcastle disease or Paragraph 2. In addition to the tests described avian influenza, salmonellas and mycoplasmas, in paragraph 1 of this article, tests for serological all imported eggs in incubation, and any other and virological research will be performed for de- 369 eggs from the same incubation machine will be tection of Newcastle disease and avian flu viruses in destroyed and have their destination defined by samples of pecked eggs, meconium and trachea col- DSA, with the intention of eliminating sanitary lected from thirty birds. The tests will be performed risks to the national poultry stock. in laboratory approved by CGAL for this purpose. Paragraph 2. In the event of existence and Art. 17. The imported day-old birds must be execution of traceability procedures in the sent exclusively to the holding of destination. Tran- hatchery that ensure the separate incubation of sit authorization for these birds will occur after con- fertile imported eggs, verified by SEDESA / SFA, clusion of quarantine tests with negative results. uncontaminated avian genetic material may be Art. 18. During the quarantine period, DSA commercialized after analysis by the DSA. may require additional material collection and Paragraph 3. Should day-old birds test posi- complementary tests. tive for Newcastle disease or avian influenza, sal- Art. 19. Boxes used for packaging and trans- monellas and mycoplasmas, all imported birds, portation of the genetic material to be imported by and any other birds from the same quarantining Brazil must be disinfected and previously unused. establishment will be destroyed and have their Art. 20. The interior and the exterior of destination defined by DSA, with the intention of the container used in the transportation of the eliminating sanitary risks to the national poultry genetic material to the shipping location of the stock. DSA will order the execution of an epide- country of origin of the cargo and in the reception of the cargo at the airport must be clean, continuing with the importation process; disinfected, and offer biosafety conditions. II – the cargo holds of the airplanes that Sole Paragraph. Biosafety in transportation carry out the international transportation of the is defined as the utilization of a closed, clima- cargo must be disinfected, using products recom- tized, sanitized and sealed vehicle in the estab- mended by OIE active against high pathogenicity lishment of origin, by the official service or by a avian influenza virus and Newcastle disease. veterinarian licensed by the official service, and and the seal must be inspected by the Official Veteri- III – should the imported birds originate nary Service of the shipping location. from different batches, all batches comprising Art. 21. The importation of genetic mate- the cargo will be submitted to the same sanitary rial intended for the restitution of the national procedure if a sanitary problem is identified in avian breeding stock may occur in the form of the imported batch. day-old birds, provided that the following spe- Art. 22. If lack of compliance with this Nor- cific zoosanitary requirements as provided for mative Instruction is identified at the time of the by Annex III and the following additional re- official inspection at the point of entry in the coun- quirements are met: try, measures will be taken to seize the imported I – in order to start the importation process batch and establish a quarantine as defined by of day-old birds, an opinion on the request from the DSA, whereas the batch will remain under the importer will be issued, as established by Min- custody and sanitary monitoring by the SEDESA / isterial Normative Instruction No. 01, of January SFA of the Federation Unit where the quarantine 14, 2004, by Ministerial Administrative Ruling No. establishment is located. Depending on the sani- 548, of August 25, 1995, and by Ministerial Nor- tary risk, destruction of the entire imported batch mative Instruction No. 6, of June 2, 2003, justify- may be determined in the point of entry. ing the initiative and zootechnical necessity, and Sole Paragraph. Batch maintenance and this documentation shall be submitted to SFA, destruction costs will be under the importer’s whereas DSA shall assess the sanitary risk before responsibility.

ANNEX II 370 ON THE ZOOSANITARY REQUIREMENTS FOR IMPORTATION OF HATCHABLE EGGS OF CHICKENS, GUINEA FOWLS, TURKEYS, QUAILS, DUCKS, GOOSES, WIDGEONS, PHEASANTS AND PARTRIDGES

Art. 1. Hatchable eggs must be accompa- and regularly inspected in an establishment nied by an International Animal Health Certifi- monitored and inspected by a veterinarian of cate, issued by a veterinarian from the Official the official service of the country of origin; Veterinary Service of the country of origin and V – that the hatchable eggs originate from a containing the following information: country or zone free from Newcastle disease and I – identification: amount, species, lineage avian influenza, notifiable under the criteria of and date of collection of the hatchable eggs; the World Organization for Animal Health – OIE; II – origin: name and address of the estab- VI – that the hatchable eggs originate from lishment of origin and exporter; mothers from stocks where no clinical case of III – destination; name and address of the Marek’s disease, avian infectious laryngotrache- hatchery, grange of destination and importer; itis, avian infectious bronchitis, infectious bursal IV – that the hatchable eggs originate from disease (Gumboro disease), fowl cholera, infec- the establishment indicated in item II of this tious avian coryza, psittacosis (avian chlamydio- article, where their mothers are born, reared sis), fowl pox, avian encephalomyelitis, reoviral infection, avian leucosis, reticuloendotheliosis, all results being negative, and that the estab- duck virus hepatitis, chicken infectious anemia lishment was free from any evidence of this and West Nile fever has been detected within disease at the time when the samples were thirty (30) days prior to the collection of the collected, mentioning: hatchable eggs; a) antigen batch number; VII – that the stock that originated the b) manufacture and expiration date; hatchable eggs received a sanitary inspection c) laboratory and date on which the tests performed by a veterinarian from the official were performed (start and end of the AGID test); service of the country of origin or by a veteri- and narian qualified by the official service, in the d) kit identification (for the ELISA); period of thirty (30) days prior to shipping, and XIII – that the hatchable eggs were disin- was free from any clinical signs of transmissible fected in the establishment of origin, by using avian diseases; an active principle that results in the inactiva- VIII – that the hatchable eggs originate tion of vegetative bacteria, fungi, lipophilic and from a stock officially declared free from Sal- hydrophilic viruses, parasites and Mycobacte- monella pullorum, Salmonella gallinarum, rium sp., mentioning: Salmonella enteritidis, Salmonella typhimu- a) the active principle; rium, Mycoplasma synoviae and Mycoplasma b) the trade name; and gallisepticum, in accordance with a program c) the concentration of the disinfectant under the supervision of the Official Veteri- used; nary Service of the country of origin, comply- XIV – that the hatchable eggs were stowed ing with the PNSA norms, and which works in in new and disinfected packages; accordance with the standards described in XV – that the transportation vehicle for the the Sanitary Hygiene and Safety Procedures hatchable eggs was closed and sealed in the es- set forth by the World Organization for Ani- tablishment of origin by the official veterinar- mal Health; ian or by a veterinarian licensed by the official IX – that the hatchable eggs originate from service, and inspected by the official service at stocks that were not vaccinated with vaccines the time of shipping; containing a modified live virus within sixty (60) XVI – that the eggs and boxes contain the days prior to collection of the exported eggs; identification of the stock of origin; 371 X – that the hatchable eggs originate from XVII – that the hatchable eggs were trans- stocks that were never vaccinated against avian ported directly from the establishment of origin influenza; to the shipping location, avoiding zones under XI – that the hatchable eggs were not vac- sanitary quarantine, in a previously disinfected cinated against any type of infectious agent, vehicle, with a disinfectant that is active against as well as were not administered antibiotics or the Newcastle disease and avian influenza vi- chemotherapies; ruses, with no contact whatsoever with other XII – that the stock that originated the birds or products of animal origin; hatchable eggs exported to Brazil was moni- XVIII – official stamp; tored for avian influenza by means of the XIX – place and date of issuance of the cer- ELISA (chickens and turkeys) or Agar Gel Im- tificate; munodiffusion (AGID) in a sample of at least XX – name and signature of the official vet- thirty (30) birds, collected by an official veterinarian; erinarian, or by a veterinarian accredited by Art. 2. Additional information may be re- the Official Veterinary Service of the country quired by the DSA, in the event of a change in of origin within thirty (30) days prior to ship- the epidemiological and sanitary status of the ping, performed in an official laboratory, with exporting country. ANNEX III

ON THE ZOOSANITARY REQUIREMENTS FOR IMPORTATION OF DAY-OLD BIRDS OF OF CHICKENS, GUINEA FOWL, TURKEYS, QUAILS, DUCKS, GOOSES, WIDGEONS, PHEASANTS AND PARTRIDGES

Art. 1. Day-old birds must be accompanied from Salmonella pullorum, Salmonella gallinar- by an International Animal Health Certificate, um, Salmonella enteritidis, Salmonella typhimu- issued by a veterinarian from the Official Vet- rium, Mycoplasma synoviae and Mycoplasma erinary Service of the country of origin and con- gallisepticum, in accordance with a program taining the following information: under the supervision of the Official Veterinary I – identification: the amount of day-old Service of the country of origin, complying birds, species, lineage and hatched date; with the PNSA norms, and that originate from II – origin: name and address of the estab- a grange that works in accordance with the lishment of origin, hatchery and exporter; norms set forth by the World Organization for III – destination; name and address of the Animal Health (OIE); quarantine establishment of destination and IX – that the day-old birds originate from importer; hatcheries that receive fertile eggs from stocks IV – that the day-old birds originate from an that have not used vaccines containing a modi- establishment indicated in item II of this article, fied live virus within sixty (60) days prior to col- where their mothers (genetic material) are born, lection of the eggs; reared and regularly inspected in establishments X – that the eggs and day-old birds did not monitored and inspected by a veterinarian of receive, while in the hatchery of origin, chemo- the official service of the country of origin; therapy treatment for any infectious agent in the V – that the day-old birds originate from a hatchery, neither were they administered antibi- country or zone free from Newcastle disease and otics or chemotherapies; avian influenza, notifiable under the criteria of XI – that the day-old birds were not vac- the World Organization for Animal Health – OIE; cinated against avian influenza, and that they VI – that the day-old birds originate from originate from stocks whose birds have not been progenitresses from stocks where no clinical case vaccinated ahainst this disease; 372 of Marek’s disease, avian infectious laryngotra- XII – that the stock that originated the day- cheitis, avian infectious bronchitis, infectious old birds exported to Brazil was monitored for bursal disease (Gumboro disease), fowl cholera, avian influenza by means of the ELISA (chickens infectious avian coryza, psittacosis (avian chla- and turkeys) or Agar Gel Immunodiffusion (AGID) mydiosis), fowl pox, avian encephalomyelitis, rein a sample of at least thirty (30) birds, collected oviral infection, avian leucosis, reticuloendothe- by an official veterinarian, or by a veterinarian liosis, duck virus hepatitis, chicken infectious licensed by the Official Veterinary Service of the anemia and West Nile fever has been detected country of origin within thirty (30) days prior to for thirty (30) days prior to the collection of the shipping, performed in an official laboratory, hatchable eggs; with all results being negative, and that the es- VII – that the stock of origin received a tablishment was free from any evidence of this sanitary inspection performed by a veterinarian disease at the time when the samples were col- from the official service of the country of origin lected, mentioning: or by a veterinarian qualified by the official ser- a) the antigen batch number; vice, within thirty (30) days prior to shipping, and b) the manufacture and expiration date; was free from any clinical signs of transmissible c) the laboratory and date on which the tests diseases; were performed (start and end of the AGID test); VIII – that the day-old birds originate from and mothers from a stock officially declared free d) kit identification (for the ELISA); XIII – that the day-old birds were stowed in tle disease and avian influenza viruses, with no new and disinfected packages; contact whatsoever with other birds or products XIV – that the transportation vehicle for the of animal origin; day-old birds was closed and sealed in the estab- XVII – that the cargo holds of the cargo air- lishment of origin by the official veterinarian or planes loaded with the day-old birds were dis- by a veterinarian licensed by the official service, infected, using products recommended by OIE and inspected by the official service at the time and FAO active against high pathogenicity avian of shipping; influenza virus; XV – that the boxes contain the identifica- XVIII – official stamp; tion of the stock of origin; XIX – place and date of certificate issuance; XVI – that the day-old birds were transport- XX – name and signature of the official vet- ed directly from the hatchery of origin to the erinarian; airport where they were shipped, avoiding zones Art. 2. Additional information may be re- under sanitary quarantine, in a vehicle with an quired by the DSA, in the event of a change in air intake filtering system, previously disinfected the epidemiological and sanitary status of the with a disinfectant that is active against Newcas- exporting country.

NORMATIVE INSTRUCTION No. 40 OF SEPTEMBER 4, 2007

Published in the Official Gazette of September 05, 2007 Section 1, Page 3

Sets the sanitary requirements for importing bovine and bubaline semen from countries outside Mercosul

The MINISTER OF AGRICULTURE, LIVESTOCK Art. 2. Without affecting the determination AND FOOD SUPPLY, in the use of the attribution of this Normative Instruction, and at the discre- granted to him by the Article 2 of the Decree tion of the Ministry of the Agriculture, Livestock 5,741 of March 30, 2006, and in accordance and Food Supply (MAPA), all previously estab- with the content of the Regulation of the Ani- lished bilateral sanitary agreements concern- 373 mal Health and Inspection Service, approved by ing the matter remain in full force in what they the Decree 24,548 of July 3, 1934, and that of don’t conflict. the Process 21000.006025/2003-48, resolves: Sole Paragraph. New sanitary agreements Art. 1. To establish the SANITARY REQUIRE- may be signed, providing they don’t contradict MENTS FOR IMPORTING BOVINE AND BUBALINE what is determined in this Normative Instruc- SEMEN FROM COUNTRIES OUTSIDE MERCOSUL, tion. in the form of the Attached Documents of this Art. 3. This Normative Instruction enters in Normative Instruction. force the day of its publication.

REINHOLD STEPHANES annex I

SANITARY REQUIREMENTS FOR IMPORTING OF BOVINE AND BUBALINE SEMEN FROM COUNTRIES OUTSIDE MERCOSUL

CHAPTER I Art. 6. When constituting the importing process at the Federal Superintendence of Agricul- GENERAL DISPOSITIONS ture, the interested party must present a copy of the DNA or blood typing test of the donor. Art. 1. Brazil will only import semen obtained in Semen Collection and Processing Cen- CHAPTER II tres (SCPC), registered and approved by the exporting country’s Official Veterinary Service. SANITARY CONDITIONS OF THE Sole Paragraph. To approve the SCPC, the EXPORTING COUNTRY exporting country’s Official Veterinary Service will consider the “CONDITIONS APPLICABLE TO ARTIFI- Art. 7. The exporting country must be free of CIAL INSEMINATION CENTRES” as well as the “CON- FMD with or without vaccination, rinderpest, con- DITIONS APPLICABLE TO SEMEN LABORATORIES” tagious bovine pleuropneumonia (Mycoplasma described in the appendix regarding the “BOVINE mycoides mycoides - small colonies) and lumpy SEMEN” of the Terrestrial Animal Health Code of skin disease, according to the recommendations the World Organisation for Animal Health (OIE). of OIE’s Terrestrial Animal Health Code. Art. 2. All semen to be imported to Bra- Sole Paragraph. In case of zoning for the zil must be accompanied of an International diseases specified in the caput of this article, the Sanitary Certificate, issued both in the exporting exporting country’s Official Service must certify country’s official language and in Portuguese that the semen was collected and processed ac- and signed or endorsed by a veterinarian of the cordingly in a SCPC located in a free area as deter- exporting country’s Official Veterinary Service, in mined by OIE’s Terrestrial Animal Health Code. conformity with the required sanitary measures of the Ministry of the Agriculture, Livestock and CHAPTER III 374 Food Supply (MAPA). Art. 3. The model of the International Sani- SEMEN DONORS tary Certificate to be used by countries outside Mer- cosul to export their bovine and bubaline semen to Art. 8. Semen donors must be born and Brazil must be previously approved by MAPA. raised in the exporting country or have stayed Art. 4. All semen imports must be previously in that country for a minimum of sixty (60) days approved by MAPA. prior to the semen donation. Art. 5. Countries certified as free of a disease Art. 9. Donors must not present any clinical are exempted from executing the diagnostic tests evidence of any semen born disease within 30 and vaccinations against that disease. (thirty) days prior to collect, at the day of collection, Paragraph 1. To achieve the certification of and in 30 (thirty) days following the collection. free country, the exporting country should present a consistent work following the recommendations CHAPTER IV of the Terrestrial Animal Health Code of OIE. Paragraph 2. The declaration of country DIAGNOSTIC TESTS free from disease should be included in the document of certification in place of execution Art. 10. The collection of sample for the lab- of testing and vaccination. oratory tests required by MAPA must be supervised by an Official Veterinarian or veterinarian noperoxidase in whole blood sample, or ELISA accredited by the Official Veterinary Service of for antigen detection or PCR at pre-quarantine the exporting country. or quarantine. Art. 11. All diagnostic tests requested by Sole Paragraph. During the stay at the SCPC, MAPA must be performed at laboratory either the resident herd must be tested every twelve official or accredited by the exporting country’s (12) months for the following diseases and pres- Official Veterinary Service. ent negative results: Art. 12. The semen should be collected in 1. BRUCELOSIS: buffered Brucella antigen a SCPC facility that fulfills the “CONDITIONS AP- test (BBAT), or complement fixation test; PLICABLE TO THE TESTING OF BULLS AND TEASER 2. TUBERCULOSIS: cervical or scapular intra- ANIMALS” as established in OIE’s Terrestrial Ani- dermal tuberculinization with bovine PPD tuber- mal Health Code, or in a SPSC that adopts the culin, comparative test with bovine and avian systematic of testing the animals that enter the PPD or caudal fold test with strong tuberculin; Centre and the resident herd, with negative re- 3. BOVINE GENITAL CAMPYLOBACTERIOSIS sults, as follows: (Campylobacter foetus subsp. venerealis): one (1) 1. When in pre-quarantine in the herd of ori- culture of prepuce secretion or immunofluores- gin of the animals: cence; a) BRUCELOSIS: buffered Brucella antigen 4. TRICHOMONOSIS: one (1) culture of pre- test (BBAT), or complement fixation test; puce secretion; b) TUBERCULOSIS: cervical intradermal tu- 5. BOVINE VIRAL DIARRHOEA: negative for iso- berculinization with bovine PPD tuberculin, lation and identification of the pathogenic agent comparative test with bovine and avian PPD or by immunofluorescence or immunoperoxidase in caudal fold test with strong tuberculin. whole blood sample, or ELISA for antigen detec- 2. When in quarantine before entering the tion or PCR at pre-quarantine or quarantine. resident herd: a) BRUCELOSIS: buffered Brucella antigen CHAPTER V test (BBAT), or complement fixation test; b) TUBERCULOSIS: cervical or scapular in- COMPLEMENTARY tradermal tuberculinization with bovine PPD tu- DIGNOSTIC TESTS berculin, comparative test with bovine and avian 375 PPD or caudal fold test with strong tuberculin; Art. 13. In case of exporting semen to Brazil, c) BOVINE GENITAL CAMPYLOBACTERIO- animals must be submitted to one of the follow- SIS (Campylobacter foetus subsp. venerealis): for ing procedures in relation to the diseases listed animals above six (6) months old: three (3) cul- below: tures of prepuce secretion sampled at minimal 1.INFECTIOUS BOVINE RHINOTRACHEITIS intervals of seven (7) days; animals below six (6) (IBR): submit one (1) blood serum sample of months old or which were kept up to this age in each semen donor to be tested by virus neutral- groups of the same gender: only one culture or ization or by ELISA, at least twenty-one (21) days immunofluorescence test is required; after the last collection of semen; or submit a d) TRICHOMONOSIS (Trichomonas foetus): for sample of frozen semen from each batch to animals above six (6) months old: three (3) cul- be exported to virus isolation test or PCR, with tures of prepuce secretion sampled at minimal negative result; and intervals of seven (7) days; for animals below six 2. BLUE TONGUE: submit one (1) sample of (6) months old or kept up to this age in groups of each semen donor’s blood serum to be tested by the same gender: only one culture is required; immunodifion in agar gel, or by ELISA with nega- e) BOVINE VIRAL DIARRHOEA (BVD): negative results in the day of the first collection of se- tive for isolation and identification of the patho- men, and again between thirty (30) and sixty (60) genic agent by immunofluorescence or immu- days after the last collection of semen; or submit a sample of each semen donor’s total blood, col- CHAPTER VII lected every 28 days, to the PCR test; or submit a sample of frozen semen from each lot to be ex- ADDITION OF ANTIBIOTICS TO SEMEN ported to the PCR test, with negative result. (NR) Art. 16. For each milliliter of frozen semen, one of the following mixtures of antibiotics must CHAPTER VI be added 1.Gentamicin (250 Tg), tylosin (50 Tg), linco- COLLECTION, PROCESSING mycin-espectinomycin (150/300 Tg); or AND STORAGE OF SEMEN 2.Penicilin (500 UI), estreptomycin (500 UI), lincomycin-espectinomycin (150/300Tg). Art. 14. All semen must be collected in a site Sole Paragraph. New antibiotic combina- that is in conformity with the recommendations tions may be used once their efficacy has been included in the “CONDITIONS APPLIED TO THE demonstrated and after being authorized by COLLECTION OF SEMEN” and processed in a site MAPA. that is in conformity with the “CONDITIONS AP- PLIED IN THE HANDLING AND PROCESSING OF SE- Chapter VIII MEN SAMPLES IN LABORATORY” described in OIE’s Terrestrial Animal Health Code. TRANSPORTATION Art. 15. All semen must be placed in individually identified straws in accordance with Art. 17. Before shipping, the container with the recommendations of OIE’s Terrestrial Ani- the semen identified in accordance with this mal Health Code and stored for a minimum of Normative Instruction must be sealed with the thirty (30) days before being exported to Brazil, official seal of the Official Veterinary Service of under supervision of the official veterinarian in the exporting country and the number of the seal charge of the SCSC. must be included in the sanitary certificate.

376 ANNEX II

Minimal information to be posted on International Sanitary Certificates for exporting bovine and bubaline semen from countries outside Mercosul to Brazil

I. Identification: Product: Import authorization number: Exporting country: II. Identification of semen from individual donors: Date of collection: Straw number: Total number of straws: III. Information from individual donors: Registration number: Breed: IV. Source: Name and address of the exporting party: Name and address of the Semen Collection and Processing Centre (SCPC):

V. Destination: Name and address of the importer party: VI. In addition to the content of incises I to V of this ANNEX, the sanitary information referred to in Articles 7 to 17 must be included.

377

NORMATIVE INSTRUCTION No. 18 OF JULY 18, 2006

Published in the Official Gazette of July 20, 2006 Section 1, Page 12

Approves the Animal Movement Permit (GTA) model to be used throughout Brazil for the transportation of live animals, fertile eggs and other materials related to animal multiplication

The BRAZILIAN MINISTER OF AGRICULTURE, Art. 1. Approve the Animal Movement Per- LIVESTOCK AND FOOD SUPPLY, by the powers mit (GTA) model to be used throughout Brazil for vested upon him pursuant to Section 87, Sole the transportation of live animals, fertile eggs Paragraph, item II, of the Brazilian Constitution, and other materials related to animal multiplica- combined with Section 2 of Decree No. 5741, of tion pursuant to the laws in effect, in the form March 30, 2006, and taking into consideration of Annex I. Process No. 21000.009775/2005-33, decided to: Paragraph 1. The GTA must be printed in accordance with the following technical specifica- the fulfillment of the health requirements estab- tions: lished by the Official Veterinary Service and by I – A4 paper, size 21.0 cm x 29.7 cm (trim the public health agencies, especially with re- area), 75-90 g or 53-55 g; spect to anti-rabies vaccination. II – text and lines in black ink, 10% gray reti- Art. 4. GTAs issued by employees of an offi- cule, with the symbol of the animal health and cial animal health control agency in any State will inspection agency on the background. be accepted, regardless of previous accreditation III – safety items must be used in the first by the Ministry of Agriculture, Livestock and Food counterpart, namely: anti-copy security back- Supply. ground, numismatic background, margins read- Sole Paragraph. The enforcing animal health ing “Brazilian Ministry of Agriculture, Livestock control agency in each State must keep a record and Food Supply” in micro letters and ultraviolet of the employees responsible for issuing GTAs, in- light-readable invisible ink with the Brazilian Na- cluding a signature bank, and must provide the tional Arms in the form of Annex II. The use of Brazilian Federal Superintendence of Agriculture, the above safety items is optional for the other Livestock and Food Supply (SFA) of the respective counterparts; and State with a list of the people in charge of issu- IV – graphical control number of the form ing the GTAs, indicating their full names, animal using a single numerical sequence for the en- species for which they are qualified to issue the tire State. document and the municipalities in which they Paragraph 2. The GTAs may only be print- are allowed to act. ed in each State provided the numbering and Art. 5. GTAs issued by Federal Agriculture control by the Brazilian Ministry of Agriculture, and Livestock Inspectors must bear the code BR, Livestock and Food Supply’s Federal Superin- a six-digit number and the series letter. tendence of Agriculture. Art. 6. GTAs issued by an enforcing animal Paragraph 3. The use of bar codes on the GTAs health and inspection agency must bear the is permitted, as long as it meets the requirements symbol of the enforcing animal health and in- and standards set forth by the Animal and Plant spection agency, the two-letter identification Health and Inspection Secretariat– SFA (Federal of the State, a six-digit number and the series Superintendence of Agriculture)/MAPA (Ministry letter. of Agriculture, Livestock and Food Supply). Art. 7. Each of the GTA’s counterparts must 378 Art. 2. The GTA must be issued based on the bear the identification and the signature of the information given on the facilities from which the issuer and the identification of the issuing unit, animals are originated and on the fulfillment of the in the form of Annex III and according to the in- health requirements established for each species. structions contained therein. Sole Paragraph. The people responsible for Art. 8. Only animal transportation docu- issuing the GTA must have received training and ments approved by this Normative Instruction instructions from the Brazilian Official Veterinary will be valid throughout Brazil. Services, pursuant to the laws in effect. Art. 9. The form of GTA approved by Admin- Art. 3. The transportation of cats and dogs istrative Ruling No. 22, of January 13, 1995, will is exempt from the GTA requirements; for this not be valid six (6) months as of the date this Nor- purpose, these animals must be accompanied mative Instruction is published. by a health certificate issued by a veterinarian Art. 10. This Normative Instruction will be duly enrolled with the State Veterinary Council of effective as of the date it is published. the State from which the animals are originated, Art. 11. Administrative Ruling No.39, of No- certifying the health status of said animals and vember 24, 2006 is revoked.

LUÍS CARLOS GUEDES PINTO ANNEX I

379 ANNEX II

Ultraviolet layout

ANNEX III 380 MODELS OF IDENTIFICATION TO BE USED IN THE ANIMAL MOVEMENT PERMITS

1. The identification of the person in charge Number of Enrollment in the State Veteri- of issuing the GTA (Animal Movement Permit) must nary Council (CRMV): Arial Narrow 11 pt font. obey the following specifications, according to the status of the issuer, and the data written on the Full Name documents must be 6 cm wide x 2.5 cm high, us- Veterinarian ing black ink when the form is filled out through a Inspection Identification Card Number computer system or blue ink when using stamps: 1.1. Identification of the Agriculture Live- Number of Enrollment in the State Veterinary stock Federal Inspector: Council (CRMV) Name of the Agriculture Livestock Federal Inspector: Arial Narrow 12 pt bold font; 1.2. Identification of the Veterinarian with Professional Education: Veterinarian: Arial the Agency Responsible for the Animal Health Narrow 11 pt font; and Inspection in each State: Inspection Identification Card Number: Arial Name of the Veterinarian: Arial Narrow 12 Narrow 11 pt font; pt bold font; Professional Education: Veterinarian: Arial 1.4. Identification of other Authorized Em- Narrow 11 pt font; ployees from Animal Health and Inspection Control number with the official animal health Agencies: and inspection agency: Arial Narrow 11 pt font; Name of Authorized Employee: Arial Narrow Number of Enrollment in the State Veteri- 12 pt bold font; nary Council (CRMV): Arial Narrow 11 pt font. Control Number at the Animal Health and Inspection Agency: Arial Narrow 11 pt font; Full Name Duties performed at the Community Office: Veterinarian Arial Narrow 11 pt font. Control Number Full Name Number of Enrollment in the State Veterinary Control Number Council (CRMV) Duties 1.3. Identification of the Accredited Veteri- narian: 2. The identification of the unit in charge of Name of the Veterinarian: Arial Narrow 12 issuing the GTA (Animal Movement Permit) must pt bold font: obey the following specifications: Education: Veterinarian: Arial Narrow 11 Name of the Issuing Unit: Arial Narrow 12 pt font; pt bold font; Number of the document proving the Veteri- Municipality: Arial Narrow 11 pt font; narian is accredited by the animal health and in- Phone Number: Arial Narrow 11 pt font; spection official agency: Arial Narrow 11 pt font; Electronic Address (when it is the case): Arial Number of Enrollment in the State Veteri- Narrow 11 pt font; nary Council (CRMV): Arial Narrow 11 pt font. Use blue ink when printing manually and black ink when printing electronically. Full Name Name of Issuing Unit Veterinarian Municipality Control Number Phone Number Number of Enrollment in the State Veterinary 381 Electronic Address Council (CRMV) NORMATIVE INSTRUCTION No. 8 OF MARCH 10, 2006

Published in the Official Gazette of March 15, 2006 Section 1, Page 26

Incorporates into the national legislation the Zoosanitary Requirements for the exchange of Bovine and Bubaline Semen among the State Parties.

THE SECRETARY OF AGRICULTURE AND LIVE- exchange of Bovine and Bubaline Semen, that STOCK HEALTH AND INSPECTION, in the use of the contains in the annex of the present Normative attributes conferred to him by art. 42, Annex I, of Instruction, approved by the Resolution GMC - Decree No. 5.351, of January 21, 2005 having in MERCOSUR No. 16, of 2005. mind the resolutions of Ouro Preto’s Protocol and Art. 2. This Normative Instruction come into Process No. 21000.006933/2005-01, resolves: force on the date of its publication. Art. 1. To incorporate to national juridi- Art. 3. Revokes the Normative Instruction cal order the zoo-sanitary requirements for the No. 18 of April 10, 2003.

GABRIEL ALVES MACIEL

ANNEX I

ZOO-SANITARY REQUIREMENTS FOR THE EXCHANGE OF BOVINE AND BUbaline SEMEN AMONG STATE PARTIES

CHAPTER I each State Party shall be responsible for granting zoo-sanitary certification to the reproducers OF GENERAL CONDITIONS and for the certification of semen quality in its hygienic-sanitary aspects, issued by Veterinary 382 Art. 1. The Semen Collection and Processing responsible for the SCPC, and certify the sanitary Centre (SCPC) shall be accredited by the Official situation of the State Party of origin. Veterinary Services of the State Party correspon- Art. 5. The SCPC shall have a logbook of dent, which shall grant a registration number activities, and it shall remain at disposal of the and shall control, at least every six months the Official Veterinary Services of the respective health and welfare of animals, as well as the se- State Party. men collection methods used and the registra- Sole paragraph. The referred registry shall tions carried out by the SCPC. contain, at least, the following data: Sole paragraph. The accreditation shall be I – identification of the resident animals: valid for one year. name, official registry number or other identifi- Art. 2. The Official Veterinary Services of cation, date of birth, when possible, blood type; each State Party shall communicate the Official II – admission date of the animals at SCPC; Veterinaries of the others State Parties the roll of III – vaccinations carried out (date, purpose, SCPC accredited, maintaining updated informa- laboratory and batch); tion in the face of change. IV – diagnostic tests carried out (tests, dates Art. 3. The SCPC shall count with a Veteri- and laboratory name); nary responsible for all the activities performed V – semen collection dates; and registrations carried out. VI – number of prepared doses; Art. 4. The Official Veterinary Services of VII – elimination of semen and its causes; VIII – date and reason for the bull’s under- tem wherever necessary; side; II – source of drinking water supply, hot and IX – number of existing semen doses at the cold, ensuring adequate quantitative and quali- time of the bull’s underside; and tative supply, for the animals’ consumption and X – comments. the performance of the cleaning and disinfection Art. 6. For the purposes of the present Nor- procedures; mative Instruction it’s understood for: III – system of collection and elimination I – Semen Collection and Processing Centre of excrements and residual water, which fulfill (SCPC): the institutions that have semen donor the requirements of the State Party where the animals, with permanent or transitory accom- SCPC is located; modation, and perform procedures of semen IV – Manure and residues deposit; collection, processing and storage. V – Insects and rodents control program; II – installations for the animals’ admittance VI – Installations built of materials that allows quarantine: area destined to accommodate ani- easy cleaning and disinfection, such as anti-ski floor- mals up to the moment they are able to become ing, on the whereas where they are necessary; part of the resident herd; VII – administration department, isolated III – Installations for accommodation of the from the areas above mentioned. resident herd: area destined to reassure the health Art. 10. the admittance quarantine, referred and welfare of the animals while residing at SCPC; to in art. 7º shall be performed in installations IV – Semen collection installations: area that count with: where the collection of semen procedures are I – the accommodation units shall ensure carried out under adequate hygiene and safety isolation conditions not allowing direct contact conditions; between the resident herd and the animals un- V - laboratory: location adequately equipped dergoing quarantine; and staffed with employees fully trained to per- II – Animal handling and restraint tools for form semen processing and storage; the performance of the clinical observations and VI – care centre: isolated area, destined to testing procedures. accommodate and treat ill animals; Art. 11. The accommodation units of the VII –changing rooms: placed destined to the resident herd, referred to in art. 10, shall be spa- changes of work attire for entering the different cious, hygienic and with easy access to the sector 383 installments of the SCPC; destined for the semen collection. VIII – Manure deposit: place to deposit the Art. 12. The semen collection sector shall manure; have protection that withstands hostile climate IX – Residue deposit: place to eliminate the condition as rain, wind and dust. SCPC residues. Art. 13. the laboratory shall be divided in three Art. 7. So as to be admitted at SCPC, every sectors conveniently separated and isolated from the animal shall undergo admittance quarantine. other installments and operationally independent. Sole paragraph. The three sectors men- CHAPTER II tioned above are: I – Sector for the preparation, cleaning, dis- OF THE INSTALLATIONS infection and sterilization of the utensils used in the semen collection and processing: this sec- Art. 8. The SCPC shall be isolated by barriers tor shall be fitted with impervious flooring and that guarantee that the resident herd will not get minimum walls impervious coating of 2 meters in contact with any other animals, persons and height, drain channels, deep sinks, counters and vehicles without the appropriate control. external openings covered with anti-insect nets; Art. 9. The SCPC shall count with: II – Sector for the preparation, testing and I – permanent ventilation and lighting sys- storage of the seminal material: this sector shall fulfill the construction requirements defined by pneumonia, Lumpy Skin Disease and the Rift item I, possess the materials required for the ex- Valley Fever, in accordance with the resolutions ecution specific requested tasks and be isolated of OIE’s Terrestrial Animal Health Code. from the collection room and only have a com- Art. 22. The State Party free from Foot munication window between them; and Mouth Disease (FMD) throughout its ter- III – Sector for conservation, storage of se- ritory or parts of it, recognized by OIE or by men containers, and dispatch of semen: this sec- the importer State Party, shall certify this tor shall meet the same building standards of the condition; the exporter State Party, that is laboratory’s other sector and have an adequate not free from FMD throughout its territory or cataloguing system to ensure the correct identifi- part of it, shall agree with the imported State cation of the seminal material. Party additional guarantees that are compat- Art. 14. The care centre shall have exclusive ible with the resolutions of the Terrestrial and adequate materials for all the procedures Animals Health Code (OIE). performed there. Art. 15. The changing rooms shall contain CHAPTER V shower facilities, adequate work attire sufficient in number for the SCPC. OF THE ANIMALS Art. 16. The manure and residual deposits shall be located at an adequate distance from the Art. 23. Shall only be admitted to the SCPC other installations so as to avoid sanitary risk. animals born and reared uninterruptedly in the Art. 17. The SCPC may have with an indepen- exporting State Party, or animals that have en- dent area for the exhibit of the breeding animals, tered the exporting State Party and have met the ensuring the maintenance of the sanitary situa- norms defined by the MERCOSUR regarding the tion. Auctions shall not be performed in the area. zoo-sanitary requirements for the cattle and buffalo exchange; in this case they must have re- CHAPTER III mained in the exporting country for at least 60 days prior to the first collection. OF THE PERSONNEL Sole paragraph. The animals imported from a third state party must have remained for Art. 18. All the personnel, when entering they must have remained in the State Party for at 384 SCPC, shall observe the hygiene and safety mea- least 60 days prior to the first collection. sures (showers, change of clothes and shoes), as Art. 24. The SCPC must immediately notify well as not getting in contact with animals which all animal casualties to the Veterinary Oficial are prone to diseases that may affect the specie. service of the State Party, stating the reason, Art. 19. The personnel shall not perform the registration number of the animal, the activities of different sanitary risks within the number of existing semen doses and data col- sectors the SCPC’s sector unless the hygiene and lection safety measures are met (showers, change of Sole paragraph. Every animal suspected clothes and shoes). to be affected by infectious diseases transmis- Art. 20. Every person that enters SCPC shall sible by semen shall be isolated; the occur- meet the hygiene and safety measures required. rence shall be immediately communicated to Official Veterinarian Services; the animal’s se- CHAPTER IV men doses shall not be commercialized until the confirmation of the diagnose, by Official OF THE STATE PARTIES OF ORIGIN Lab; the destination of the stored semen shall be determined by order from the Official Vet- Art. 21. The exporting State Party shall be erinarian Services. free of Rinderpest, Contagious Bovine Pleuro- Art. 25. In case the resident herd, for any reason, leaves the SCPC premises, they shall un- being tested, with negative results, for the fol- dergo admittance quarantine to able to return. lowing diseases: I - Brucellosis: buffered brucella antigen test CHAPTER VI (BBAT/BPA)/Rose Bengal test; the animals that present tests with positive results shall be under- OF THE DIAGNOSTIC TESTING go the complement fixation or 2-mercaptoethanol Brucella agglutination test or ELISA; Art. 26. Further diagnostic testing and pro- II - Tuberculosis: Delayed hypersensitiv- cedures, other then those listed in the present ity test Normative Instruction, with the same equiva- III – Bovine Genital Campylobacteriosis: lent guarantees for the exchange of bovine and culture of prepucial smegma or immunofluores- bubaline semen, may be agreed between and cence test; importing and exporting State Parties. IV - Trichomonosis: 4 weekly tests of prepucial smegma culture, with negative results; CHAPTER VII V – Bovine Viral Diarrhea (BVD): isolation and identification of the causative agent by OF THE ZOO-SANITARY immunofluorescence or immunoperoxidase in PROCEDURES PRIOR TO THE a whole blood or blood serum sample; 2 tests QUARANTINE. shall be carried out; if the first one presents positive results, the test shall be repeated after Art. 27. To be admitted at the SCPC, the a 14 days interval; of the second tests presents animals shall be accompanied by a zoo-sanitary negative results, the admittance of the animal certificate, issued by the official veterinary or shall be authorized. person responsible for the SCPC, stating that in the establishment of origin there haven’t been CHAPTER IX any occurrences of diseases transmissible by semen that affects the specie for the last 90 days, OF THE ZOO-SANITARY and that the animals have been tested, with neg- PROCEDURES FOR THE RESIDENT HERD ative results, for the following diseases: I – Tuberculosis: Delayed hypersensitivity test; Art. 30. The resident herd shall be diagnos- 385 II -Brucellosis: buffered brucella antigen tic tested every 180 days, with negative for the test (BBAT/BPA)/Rose Bengal test; the animals following diseases: that present tests with positive results shall be I - Brucellosis: buffered brucella antigen undergo the complement fixation or 2-mercap- test (BBAT/BPA)/Rose Bengal test; the animals toethanol Brucella agglutination test or ELISA. that present tests with positive results shall be undergo the complement fixation or 2-mer- CHAPTER VIII captoethanol Brucella agglutination test or ELISA test; OF THE QUARANTINE II - Tuberculosis: Delayed hypersensitiv- ZOO-SANITARY PROCEDURES ity test III – Bovine Genital Campylobacteriosis: Art. 28. With regards to vesicular estomati- culture of prepucial smegma or immunofluores- tis, the animals that enter centre shall meet the cence test; correspondent regulations defined by the OIE’s IV - Trichomonosis: 4 weekly tests of prepu- Terrestrial Animal Health Code. cial smegma culture; Art. 29. The animals shall be kept in quar- Art. 31.The animals of the resident herd, antine for a minimum period of 30 days, and which the semen will be exported, shall be tested, shall only become part of the resident herd after with negative results, for the following diseases: I – Infectious Bovine Rinotracheitis (IBR): Sole paragraph. In this case, the exporter virus neutralization test or ELISA carried out at State Party shall certify this condition, and the least 21 days after the last semen collection; or SCPC shall have official certification of establish- a 0,5ml sample of processed semen of each lot ment free from diseases, issued by the Official shall be tested by virus isolation or PCR; Veterinarian Services of the respective State Party, II – Blue Tongue: agar-gel immunodiffu- part of a national eradication program. sion test or ELISA, carried out 40 days after the last semen collection or a sample of whole- CHAPTER X blood from the semen donor collected every 14 days submitted to virus isolation test or PCR, or OF THE SEMEN submit a 0,5ml sample of processed semen for each PCR lot; Art. 34. The semen shall be collected and III – Enzootic Bovine Leukosis (EBL): Agar processed in accordance with the Terrestrial Ani- Gel immunodiffusion test or ELISA on a serum mal Health Code (OIE). obtained at least 30 days after the last semen col- Art. 35. The semen shall be stored for a pe- lection; or submit a 0,5 ml sample of processed riod of 45 days from the collection date, at the semen from each lot to PCR; SCPC installations. Sole paragraph. A 0,5 ml sample of semen Art. 36. For the exchange among the State may be used for diagnostic testing for the diseas- Parties, the bovine and bubaline semen shall be es cited in the items of this article. accompanied by the Zoo-sanitary Certificate for Ex- Art. 32. The animals belonging to the resi- change of Bovine and Bubaline Semen among the dent herd with positive results for the diseases State Parties, in accordance with the model found listed in this chapter shall be isolated and reeval- in Annex II of the present Normative Instruction. uated by the Official Veterinarian Services of the Paragraph 1. The referred certificate shall respective State Party, which shall determine the be signed by the Veterinary responsible for the destination of the animals. SCPC and countersigned by the official veterinary Art. 33. Diagnostic testing for the diseases of the exporting State Party. mentioned in art. 31 shall not be necessary when Paragraph 2. All the certificate sheets shall the State Party is free of those diseases, through- be sequentially numbered, stamped and signed out its territory or parts of the territory, in face of by the Veterinary of the exporting country Offi- 386 OIE’s or the importer State Party recognition. cial Services. ANNEX II

ZOOSANITARY CERTIFICATE FOR THE TRADE IN BOVINE AND BUBALINE SEMEN AMONG STATES PARTIES

Certificate Nº. Seal Nº. Date issued Expiration date

I. ORIGIN State Party State SCPC Registration Nº. SCPC name and address Exporter’s name Exporter’s address

II. DESTINATION State Party State Importer’s name Importer’s address

III. TRANSPORTATION Means of transportation 387 Exit point in the State Party

IV. IDENTIFICATION OF SEMEN DONOR(S) Donor animal’s Breed Date of entry in Number of doses Date of semen registration n°. the SCPC collection V. HEALTH INFORMATION in this certificate, were submitted, respectively, to The official veterinary certifies that the SCPC com- diagnostic testing, with negative results, for the plies with the requirements defined by the Reso- following diseases: lution GMC No. 16/05 related to “The Zoo-sanitary One sample of the same lot, enclosed on Requirements for Exchange of Bovine and Buba- this certificate, was submitted to three diagnostic line Semen among the State Parties”. tests, with negative results: VI. DIAGNOSTIC TESTS OF THE SEMEN DONORS At every 180 days, the semen donors shall be a. INFECTIONS BOVINE RHINOTRACHEITIS submitted, with negative results, to the following (IBR): diagnostic tests: virus isolation or PCR a. BRUCELLOSIS: buffered brucella antigen Date _____/_____/_____ test (BBAT/BPA)/Rose Bengal test; the animals b. BLUE TONGUE (BT): that present tests with positive results shall be PCR undergo the complement fixation or 2-mercapto- Date _____/_____/_____ ethanol Brucella agglutination test or ELISA. c. ENZOOTIC BOVINE LEUKOSIS (EBL): b. TUBERCULOSIS: Delayed hypersensitiv- PCR ity test. Date_____/_____/_____ c. BOVINE GENITAL CAMPYLOBACTERIOSIS: VIII. DO TRANSPORTE DO SÊMEN culture of prepucial smegma or immunofluores- 1. The isothermal containers used to store cence test; and transport the semen were cleaned and disin- d. TRICHOMONOSIS: 4 weekly tests of prepu- fected adequately with products which were of- cial smegma culture. ficially approved by the exporter State Party. e. INFECTIONS BOVINE RHINOTRACHEITIS 2. The isothermal containers were sealed by (IBR): virus neutralization test or ELISA. the Official Veterinarian Services of the exporting f. BLUE TONGUE: agar-gel immunodiffusion State Party or by the Veterinary responsible for test or ELISA, PCR test or virus isolation test of the SCPC. whole-blood. PLACE AND DATE g. ENZOOTIC BOVINE LEUKOSIS (EBL): Agar NAME AND SIGNATURE OF THE VETERINARY Gel immunodiffusion test or ELISA RESPONSIBLE FOR THE SCPC VII. DIAGNOSTIC TESTING FOR SEMEN NAME AND SIGNATURE OF THE OFFICIAL VET- 388 Three samples of each semen lot, enclosed ERINARY

NORMATIVE INSTRUCTION No. 80 OF NOVEMBER 11, 2004

Published in the Official Gazette of December 02, 2004 Section 1, Page 7

Incorporates into national legislation “Zoosanitary and Embarkation Certificate Models and Zoosanitary Requisites for the Exchange of Cattle for Rearing and Fattening between Member States of MERCOSUL,” approved by MERCOSUL GMC Resolution No. 31/03 that counts as an annex to this Normative Instruction.

THE MINISTRY OF AGRICULTURE, LIFESTOCK Section II, of Decree No. 4,629 of March 21, AND FOOD SUPPLY’S SECRETARY OF ANIMAL 2003 and also taking into consideration terms AND PLANT HEALTH AND INSPECTION, through of the Protocol of Ouro Preto and Process No. the jurisdiction conferred to it by Article 15, 21000.004137/2004-45 resolves: Art. 1. To incorporate into national law approved by MERCOSUL GMC Resolution No. the “Zoo-sanitary and Embarkation Certificate 31/03 that counts as an annex to this Norma- Models and Zoo-sanitary Requisites for the tive Instruction. Exchange of Cattle for Rearing and Fatten- Art. 2. This Normative Instruction will enter ing between Member States of MERCOSUL,” in vigour on the date of publication.

MAÇAO TADANO

ANNEX 1

ZOO-SANITARY REQUISITS FOR THE EXCHANGE OF CATTLE FOR REARING AND FATTENING BETWEEN MEMBER STATES OF MERCOSUL

CHAPTER I the exportation quarantine was carried out. 4. Any MERCOSUL Member State with an GENERAL ARRANGEMENTS official programme of control or eradication for any disease not mentioned in this Annex All cattle importations destined for rear- reserves the right to require addition measures ing and fattening will be accompanied by a of protection, including tests, in order to pre- Zoo-Sanitary Certificate issued by the Official vent the entrance of disease into the country. Veterinary Service pertaining to the Member Where this is the case, the Member State must State of Origin. provide a guarantee of the same standards Zoo-Sanitary Certificates will be issued by when exporting animals to other Member the Official Veterinary Service of each Member States of MERCOSUL. State, in accordance with the models shown in 5. The exporting Member State must provide Annexes II and III that must be approved by all information necessary in order to comply Member States. with the requirements of the Official Tracking 1. The issue of the Zoo-Sanitary Certificate Programme of the importing Member State. will be executed within a period exceeding no 6. In the event of non-compliance with 389 longer than 72 (seventy-two) hours before em- any protection measure included in this Annex, barkation after the presentation of import au- sanctions agreed upon by Member States of thorisation from the importing country. MERCOSUL may be adopted. 2. Additional certification will be included 7. The animals must be quarantined by the at the moment of embarkation, after clinical Member State of Origin in an officially-approved inspection of the animals to confirm compli- locale, observing all relevant requirements for ance with sanitary rules established by this a minimum period of 30 (thirty) days. If neces- Resolution. sary, samples will be taken under official super- 3. For the purposes of this Resolution, all vision in order for laboratory tests, treatments definitions are those found in the Terrestrial and vaccinations to be performed. Animal Health Code of the World Animal Health 8. Laboratory examinations required dur- Organisation (OIE), with the addition of the fol- ing the quarantine period will be carried out lowing: by official laboratories or those accredited by ORIGINATING ESTABLISHMENT: The local the Official Veterinary Service of the originating where the animals were either born or kept in Member State. These examinations will be valid the twelve months prior to exportation. throughout the animal’s stay in quarantine for DEPARTURE ESTABLISHMENT: The local where a period not exceeding 60 (sixty) days. 9. The importer has the right to demand The Member State or the zone of the Mem- additional tests for diseases not mentioned in ber State from where the animals originate must this Annex but for which it has a particular in- be free of Foot-and-Mouth disease without vac- terest in controlling or preventing. This matter, cination and this condition must be recognised however, will be agreed upon between the im- by the importing Member State; or porter and exporter and not subject to an of- The Member State of the zone of the Mem- ficial certificate. ber State from where the animals originate must 10. The exporting Member State must com- be free of Foot-and-Mouth disease with vacci- ply with the laws relating to anabolic substanc- nation and this condition must be recognised es of the importing Member State. by the importing Member State (this condition applies to the importing Member State with the CHAPTER II same sanitary status or with an inferior sanitary status to the exporting country); or ZOO-SANITARY ARRANGEMENTS In the event of non-compliance with the conditions established in this section, the im- 11. The MERCOSUL Member State of Origin porter and exporter Member States may togeth- must be officially free of Rinderpest, Contagious er establish measures based on the Terrestrial Bovine Pleuropneumonia, Rift Valley Fever and Animal Health Code of the OIE in the Chapter Lump Skin Disease, in accordance with the Ter- corresponding to Foot-and-Mouth disease restrial Animal Health Code of the OIE. aimed at maintaining the exchange of cattle In the event of the introduction of any dis- and buffalo for rearing and fattening. ease referred to in this section, Member States 13.3. VESICULAR STOMATITIS will convene to determine the possibility of an The Member State or the zone of the Mem- exclusion zone and other complementary mea- ber State from where the animals originate sures to ensure the continuation of importa- must be free of Vesicular Stomatitis and this tions and exportations. condition must be recognised by the importing 12. The animals must have been born and member state; or raised in the originating Member State or in The animals must come from an establish- any of the other Member States of MERCOSUL. ment where, within a radius of 15km, there Where animals have been imported from a have been no registered cases of Vesicular 390 third-party country, the exportation will only be Stomatitis in the past 30 (thirty) days; permitted if the importing country has received In addition, during the period of quaran- prior notification of origin. tine the animals will be submitted to Virus Neu- 13. With respect to: tralisation tests (positive > 1.6) or ELISA (posi- 13.1. BOVINE SPONGIFORM ENCEPHALOPA- tive > 1.3) with negative results for the types THY (BSE) of virus known to exist in the Member State of The disease must not have been registered Origin. in the Member State of Origin; 13.4. BRUCELLOSIS The disease must require compulsory noti- The Member States should be free of Bru- fication in the Member State of Origin; cellosis or contain a zone free of Brucellosis in The Member State of Origin has legislation accordance with rules established by the OIE’s enacted prohibiting the use of proteins ob- Terrestrial Animal Health Code; or tained from animals that can transmit BSE for The animals must originate from an estab- the feed of ruminants; lishment free of Brucellosis in accordance with The Member State of Origin must have a rules established by the OIE’s Terrestrial Animal system of vigilance in force to detect the even- Health Code; or tual occurrence of the disease in the country. The animals will be submitted to the 13.2. FOOT-AND-MOUTH DISEASE BBAT or ELISA or Complement Fixation Test during the quarantine period. The animals will be submitted to the In- Females less than 24 (twenty-four) months tradermal Tuberculin Test with bovine PPD or old vaccinated with the B19 vaccine up until bovine and avian PPD and receive a negative the age of 8 (eight) months are not required to result during the quarantine period. undergo diagnostic tests for Brucellosis. In this 14. The animals to be exported must not case, an additional declaration of vaccination be subjected of disposal because of a disease should be included in the certificate. control or eradication programme in force in Young steers are also not required to un- the Member State of Origin. dergo diagnostic tests for Brucellosis. 15. The animals must be submitted treat- 13.5.TUBERCULOSIS ment against internal and external parasites. The Member State of Origin must be free 16. The animals must not present any of Tuberculosis or possess a zone free of Tuber- clinical sign of transmissible disease during the culosis in accordance with rules established by quarantine period. the OIE’s Terrestrial Animals Sanitary Code; or 17. The animals must be inspected at the The animals must come from an estab- moment of embarkation by an official veteri- lishment free of tuberculosis in accordance narian who will issue an additional certificate with rules established in the OIE’s Terrestrial confirming the conditions of the animals and Animals Sanitary Code; or their method of transportation.

391 ANNEX II

MODEL OF ZOOSANITARY CERTIFICATE FOR TRADE OF CATTLE FOR REARING AND FATTENING AMONG MERCOSUR STATE PARTIES

Exporting State Party: Agency: Name of service: Province or Municipality, etc:

I. ANIMALS’ IDENTIFICATION Individual identification Breed Gender Age

II. ANIMALS’ ORIGIN Exporter’s name:

Address:

Name of the establishment of origin:

Address: 392

III. ANIMALS’ DESTINATION Exporter’s name:

Address:

Means of transportation:

IV. SANITARY INFORMATION

Information required under Annex I hereto should be provided.

Official Veterinary Service Veterinarian’s name stamp and seal ANNEX III

MODEL OF SHIPPING CERTIFICATE FOR CATTLE FOR REARING AND FATTENING DESTINED FOR MERCOSUR STATES PARTIES.

Exporting State Party: Agency: Name of Service:

The Exporting State Party’s official veterinary hereby testifies that the animals identified in the Zoo- sanitary Certificate , which are destined for exportation to (Name of the Destination State Party):

1. Were examined at the time of shipping and found to be in sound physical conditions, as well as free of external parasites.

2. Were transported on vehicles that were previously cleaned and disinfected with products registered with the State Party’s Official Veterinary Services, so as to prevent direct contact with animals in adverse health conditions, all in accordance with specific transportation requirements.

Shipping place: Date:

Means of transportation:

Transportation vehicles’ tag nos.:

Seal nº.: 393

Official Veterinary Official veterinary’s Service signature and seal NORMATIVE INSTRUCTION No. 69 OF SEPTEMBER 15, 2004

Published in the Official Gazette of September 23, 2004 Section 1, Page 15

Incorporates into national legislation “Zoosanitary and Embarkation Certificate Models and Zoosanitary Requisites for the Exchange of Cattle and Buffalos for Reproduction between Member States of MERCOSUL.”

THE MINISTRY OF AGRICULTURE, LIFESTOCK Models and Zoo-Sanitary Requisites for the AND FOOD SUPPLY’S SECRETARY OF ANIMAL Exchange of Cattle and Buffalo for Reproduc- AND PLANT HEALTH AND INSPECTION, through tion between Member States of MERCOSUL,” the jurisdiction conferred to it by Article 15, approved by MERCOSUL GMC Resolution No Section II, of Decree No. 4,629 of March 21, 30/03, that counts as an annex to this Norma- 2003 and also taking into consideration terms tive Instruction. of the Protocol of Ouro Preto and Process No. Art. 2. This Normative Instruction will enter 21000.004136/2004-09 resolves: in vigour on the day of its publication. Art. 1. To incorporate into national law Art. 3. Normative Instruction No.19 of April the “Zoo-Sanitary and Embarkation Certificate 10, 2003 is hereby revoked.

MAÇAO TADANO

ANNEX I

ZOO-SANITARY REQUISITES FOR THE EXCHANGE OF CATTLE AND BUFFALO FOR REPRODUCTION BETWEEN MEMBER STATES OF MERCOSUL

394 CHAPTER I the moment of embarkation, after clinical inspection of the animals to confirm compliance with GENERAL ARRANGEMENTS sanitary rules established by this Resolution. 4. For the purposes of this Resolution, all 1. All cattle and buffalo importations des- definitions are those found in the Terrestrial tined for reproduction will be accompanied by a Animal Health Code of the World Animal Health Zoo-Sanitary Certificate issued by the Official Vet- Organisation (OIE), with the addition of the fol- erinary Service pertaining to the Member State of lowing: Origin or Source. Zoo-Sanitary Certificates will be ORIGINATING ESTABLISHMENT: The local issued by the Official Veterinary Service of each where the animals were either born or kept in Member State, in accordance with the models the twelve months prior to exportation. shown in Annexes II and III that must be ap- DEPARTURE ESTABLISHMENT: The local proved by Member States. where the exportation quarantine was carried 2. The issue of the Zoo-Sanitary Certificate out. will be executed within a period exceeding no 5. Any MERCOSUL Member State with an offi- longer than 72 (seventy-two) hours before em- cial programme of control or eradication for any barkation after the presentation of import au- disease not mentioned in this Annex reserves the thorisation from the importing country. right to require addition measures of protection, 3. Additional certification will be included at including tests, in order to prevent the entrance of disease into the country. Where this is the case, 12. The animals must have been born and the Member State must provide a guarantee of raised in the originating Member State or in any the same standards when exporting animals to of the other Member States of MERCOSUL. Where other Member States of MERCOSUL. animals have been imported from a third-party 6. The exporting Member State must provide country, the exportation will only be permitted if all information necessary in order to comply with the importing country has received prior notifica- the requirements of the Official Traceability Pro- tion of origin. gramme of the importing Member State. 13. With respect to: 7. In the event of non-compliance with any 13.1. BOVINE SPONGIFORM ENCEPHALOPA- protection measure included in this Annex, sanc- THY (BSE) tions agreed upon by Member States of MERCO- The disease must not have been registered SUL may be adopted. in the Member State of Origin; 8. The animals must be quarantined by the The disease must require compulsory notifi- Member State of Origin in an officially-approved cation in the Member State of Origin; locale, observing all relevant requirements for a The Member State of Origin has legislation minimum period of 30 (thirty) days. If necessary, enacted prohibiting the use of proteins obtained samples will be taken under official supervision from animals that can transmit BSE for the feed in order for laboratory tests, treatments and vac- of ruminants; cinations to be performed. The Member State of Origin must have a sys- 9. Laboratory examinations required during tem of vigilance in force to detect the eventual the quarantine period will be carried out by of- occurrence of the disease in the country. ficial laboratories or those accredited by the Offi- 13.2. FOOT-AND-MOUTH DISEASE cial Veterinary Service of the originating Member The Member State or the zone of the Mem- State. These examinations will be valid through- ber State from where the animals originate must out the animal’s stay in quarantine for a period be free of Foot-and-Mouth disease without vac- not exceeding 60 (sixty) days. cination and this condition must be recognised 10. The importer has the right to demand by the importing Member State; or additional tests for diseases not mentioned in this The Member State of the zone of the Mem- Annex but for which it has a particular interest in ber State from where the animals originate must controlling or preventing. This matter, however, be free of Foot-and-Mouth disease with vaccina- 395 will be agreed upon between the importer and tion and this condition must be recognised by the exporter and not subject to an official certificate. importing Member State (this condition applies to the importing Member State with the same CHAPTER II sanitary status or with an inferior sanitary status to the exporting country); or ZOO-SANITARY ARRANGEMENTS In the event of non-compliance with the conditions established in this section, the im- 11. The MERCOSUL Member State of Origin porter and exporter Member States may together must be officially free of Rinderpest, Contagious establish measures based on the Terrestrial Ani- Bovine Pleuropneumonia, Rift Valley Fever and mal Health Code of the OIE in the Chapter cor- Lumpy Skin Disease, in accordance with the Ter- responding to Foot-and-Mouth disease aimed at restrial Animal Health Code of the OIE. maintaining the exchange of cattle and buffalo In the event of the introduction of any dis- for reproduction. ease referred to in this section, Member States 13.3 VESICULAR STOMATITIS will convene to determine the possibility of an The Member State or the zone of the Member exclusion zone and other complementary mea- State from where the animals originate must be sures to ensure the continuation of importations free of Vesicular Stomatitis and this condition must and exportations. be recognised by the importing member state; or The animals must come from an establish- The animals must come from an establishment where, within a radius of 15km, there have ment free of tuberculosis in accordance with been no registered cases of Vesicular Stomatitis rules established in the OIE’s Terrestrial Animals in the past 30 (thirty) days; Sanitary Code; or In addition, during the period of quarantine The animals will be submitted to the Intrad- the animals will be submitted to Virus Neutralisa- ermal Tuberculin Test with bovine PPD or bovine tion tests (positive > 1.6) or ELISA (positive > 1.3) and avian PPD and receive a negative result dur- with negative results for the types of virus known ing the quarantine period. to exist in the Member State of Origin. 13.6. BOVINE VIRAL DIARRHOEA (BVD) 13.4. BRUCELLOSIS The animals must be subjected to viral isola- The Member State of Origin should be free tion tests or ELISA for the detection of viral anti- of Brucellosis or contain a zone free of Brucellosis gens in total blood samples, the results of which in accordance with rules established by the OIE’s must be negative during the quarantine period. Terrestrial Animal Health Code; or Animals that show positive from the first test The animals must originate from an estab- must be subjected to a second test with a mini- lishment free of Brucellosis in accordance with mum interval of 14 (fourteen) days. Should the rules established by the OIE’s Terrestrial Animal second test prove negative, the animal shall be Health Code; or qualified for exportation. The animals will be submitted to the BBAT 14. The animals to be exported must not be or ELISA or Complement Fixation Test during subjected of disposal because of a disease control the quarantine period. Females less than 24 or eradication programme in force in the Mem- (twenty-four) months old vaccinated with the ber State of Origin. B19 vaccine up until the age of 8 (eight) months 15. The animals must be submitted treat- are not required to undergo diagnostic tests for ment against internal and external parasites. Brucellosis. In this case, an additional declara- 16. The animals must not present any clini- tion of vaccination should be included in the cal sign of transmissible disease during the quar- certificate. antine period. 13.5.TUBERCULOSIS 17.An official veterinarian who will issue an The Member State of Origin must be free of additional certificate confirming the conditions Tuberculosis or possess a zone free of Tubercu- of the animals and their method of transporta- 396 losis in accordance with rules established by the tion must inspect the animals at the moment of OIE’s Terrestrial Animals Sanitary Code; or embarkation. ANNEX II

MODEL OF ZOOSANITARY CERTIFICATE FOR TRADE OF CATTLE AND BUFFALO FOR REPRODUCTION AMONG MERCOSUR STATES PARTIES

Exporting State Party: Agency: Service: Province or Municipality, etc.:

I. ANIMALS’ IDENTIFICATION Individual identification Breed Gender Age

II. ANIMALS’ ORIGIN Exporter:

Address:

Establishment of origin:

Address:

III. ANIMALS’ DESTINATION 397 Exporter:

Address:

Means of transportation:

IV. SANITARY INFORMATION

Information specified in Annex I hereto should be provided.

Official Veterinary Veterinarian’s name Service stamp and signature ANNEX III

MODEL OF SHIPPING CERTIFICATE FOR CATTLE AND BUFFALO FOR REPRODUCTION DESTINED FOR MERCOSUR MEMBER COUNTRIES.

Exporting State Party: Agency: Service:

I, Official Veterinarian of the exporting State Party, hereby certify that the animals identified in Zoo- sanitary certificate No. , destined for exportation to (Name of destination State Party):

1. Have been examined at the time of shipment and on that occasion were in good physical condition as well as free of external parasites.

2. Were being transported in vehicles that had been previously cleaned and disinfected with products approved by the Official Veterinary Services of the State Party of Origin, so as to avoid direct contact with animals in adverse sanitary condition, and in accordance with specific transportation requirements.

Shipping location: Date:

Means of transportation:

Transportation vehicle’s tag number:

Seal’s number: 398

Official Veterinary Official Veterinarian’s Service stamp name and signature NORMATIVE INSTRUCTION No. 61 OF AUGUST 30, 2004.

Published in the Official Gazette of September 21, 2004 Section 1, Page 9

Incorporates to the national legislation the “Zoosanitary requirements for the Exchange of Cattle for Immediate Slaughter among the Member States of the Mercosur and the Zoo- sanitary Certificate and Embarkation Certificate Models.”

THE SECRETARY OF ANIMAL AND PLANT the Exchange of Cattle for Immediate Slaughter HEALTH AND INSPECTION, in the use of the at- among the Member States of the Mercosur and tributes conferred to him by art. 15, item II, of the Model Zoo-sanitary Certificate and Model Em- Decree No. 4.629, of March 21, 2003, having in barkation Certificate” approved by the Resolution mind the resolutions of Ouro Preto’s Protocol and GMC - MERCOSUR No. 32/03, which is enclosed as Process No. 21000.004138/2004-90, resolves: annex of the present Normative Instruction. Art. 1. To incorporate to the national ju- Art. 2. This Normative Instruction comes ridical order the “Zoo-sanitary requirements for into force on the date of its publication.

CEZAR WILSON MARTINS DA ROCHA

ANNEX I

ZOO-SANITARY REQUIREMENTS FOR THE EXCHANGE OF CATTLE AND BUFFALO FOR IMMEDIATE SLAUGHTER AMONG THE MEMBER STATES OF THE MERCORSUR

CHAPTER I 3. Additional Certification shall be enclosed 399 at the moment of embarkation, after clinical GENERAL COMMENTS inspection of the animals, attesting the sanitary conditions as defined by the present Resolution. 1. Every import of cattle and buffalo for 4. For the purposes of this Resolution, the immediate slaughter shall be accompanied by definitions stated in the Terrestrial Animal Heath a Zoo-sanitary Certificate issued by the Official Code (OIE) shall be adopted and understood as Veterinarian Services of State Party origin of follows: the animals. ESTABLISHMENT OF ORIGIN: place of birth The zoo-sanitary certificates to be issued the or where the animals had spent their last 12 Official Veterinarian Services of each Member months immediately prior to the export date. State, shall be in accordance with the models ESTABLISHMENT OF PROVENIENCE: where present in Annex II and III, and shall be submit- the quarantine for export was carried out. ted to the approval of the other Member States. 5. The Member State of the MERCOSUR 2. The issue of the zoo-sanitary certificate which adopts an official program of control or shall be carried out in a period no longer than eradication of any disease contemplated in the 72 hours prior to embarkation, through pre- present Annex, reserves the right to request pro- senting the importation authorization from the tection measures, including diagnostic tests, so importing country. as to prevent the ingress of the disease in its territory. In this case, the Member State shall grant which prohibit the use of animal protein, as they the same guarantees when exporting animals to may transmit BSE, in all ruminant feeds; the other MERCOSUR Member States. The Member State of Origin shall have a 6. The exporting Member State shall surveillance system to detect the eventual occur- grant the information necessary to allow the rence of the disease in the country. compliance with the requirements of Official 11.2. FOOT AND MOUTH DISEASE (FMD) Traceability Program of the importing Mem- The Member State or part of its territory, ber State. where the animals come from, shall be free of 7. In case of failure to comply with any pro- FMD without vaccination and this condition tection measure recommended in the present shall be recognized by the importing Member Annex, equivalent measures may be adopted, as State; or long as they have been agreed among the MER- The Member State or part of its territory, COSUR Member States. where the animals come from, shall be free of 8. The exporting Member State shall com- FMD with vaccination and this condition shall be ply with the current legislation of the importing recognized by the importing Member State (this Member State with regards to use of anabolic condition is applicable to an importing Member substances. State with the same or inferior sanitary status as the exporting Member State); or CHAPTER II In case of non-compliance with the required conditions of this item, the importing and ex- ZOO-SANITARY INFORMATION porting Member States, together, may establish conditions based on the chapter with regards to 9. A MERCOSUR Member State shall be of- FMD of the OIE’s Terrestrial Animal Health Code, ficially free from Rinderpest, Contagious Bovine so as to maintain the exchange of bovine and Pleuropneumonia, Lumpy Skin Disease and the buffalo for immediate slaughter. Rift Valley Fever, according to OIE’s Terrestrial 11.3. VESICULAR ESTOMATITIS Animal Health Code. The Member State, or part of its territory, In the event of the introduction of any dis- where the animals come from shall be free from ease referred to in this section, Member States Vesicular Estomatitis, and this condition shall be will convene to determine the possibility of an certified by the importing Member State; or 400 exclusion zone and other complementary mea- The animals shall come from an establish- sures to ensure the continuation of importations ment where there haven’t been registered occur- and exportations. rences of vesicular estomatitis for the last 30 days 10. The animals shall be born and bred in within a 15 km radius of the establishment. Member State of origin, or in any other MERCO- 12. The animals to be exported shall be sub- SUR’s Member States. jected of disposal, due to a control and/or eradi- 11. With regards to: cation of diseases program in execution in the 11.1. SPONGIFORM ENCEFALOPHATIES (BSE) Member State of origin. The disease mustn’t have been registered at 13. The animals shall be inspected at the the Member State of origin; embarkation moment by an official veterinary, The disease shall be of mandatorily notifica- who shall issue an additional certification attest- tion in the Member State of origin; ing the transport conditions and the animals’ The Member State of origin shall have laws clinical condition. ANNEX II

MODEL OF ZOOSANITARY CERTIFICATE FOR THE EXCHANGE OF CATTLE FOR IMMEDIATE SLAUGHTER AMONG THE MEMBER STATES OF THE MERCORSUR

Exporting State Party: Agency: Service: Province or Municipality, etc.:

I. ANIMALS’ IDENTIFICATION Individual identification Breed Gender Age

II. ANIMALS’ ORIGIN Exporter:

Address:

Establishment of origin:

Address:

III. ANIMALS’ DESTINATION 401 Exporter:

Address:

Means of transportation:

IV. SANITARY INFORMATION

Information specified in Annex I hereto should be provided.

Official Veterinary Veterinarian’s name Service stamp and signature ANNEX III

MODEL OF SHIPPING CERTIFICATE FOR THE IMMEDIATE SLAUGHTER OF CATTLE AMONG THE MEMBER STATES OF THE MERCORSUR.

Exporting State Party: Agency: Service:

I, Official Veterinarian of the exporting State Party, hereby certify that the animals identified in Zoo- sanitary certificate No. , destined for exportation to (Name of destination State Party):

1. Have been examined at the time of shipment and on that occasion were in good physical condition as well as free of external parasites.

Shipping location: Date:

Means of transportation:

Transportation vehicle’s tag number:

Seal’s number: 402

Official Veterinary Official Veterinarian’s Service stamp name and signature NORMATIVE INSTRUCTION SDA No. 48 OF JUNE 17, 2003

Published in the Official Gazette of June 20, 2003 Section 1, Page 6

Bovine and bubaline semen may be distributed in Brazil only if collected at Semen Collection and Processing Centers-SCPC registered with the Ministry of Agriculture, Livestock, and Food Supply and which are in compliance with minimum requirements for the production and marketing of bovine and bubaline semen in the country.

THE MINISTRY OF AGRICULTURE, LIVESTOCK ANCE WITH MINIMUM REQUIREMENTS FOR THE AND FOOD SUPPLY’S ANIMAL AND PLANT HEALTH PRODUCTION AND MARKETING OF BOVINE AND AND INSPECTION SECRETARY, by virtue of the BUBALINE SEMEN IN THE COUNTRY, pursuant to powers vested in him under Art. 15, II of Decree the Annexes hereto. No. 4629 of March 21, 2003, Sole Paragraph. To be registered, SCPC must Whereas it is necessary to establish sanitary follow this Ministry’s current norms. measures to ensure the quality of semen pro- Art. 2. To delegate to the Director of the Ani- duced and marketed in Brazil, and mal Health and Inspection Department the com- In view of the provisions of Proceeding No. petence for issuing complementary acts that may 21000.001909/2002-25, be necessary for enforcement of this Normative RESOLVES: Instruction. Art. 1. Bovine and bubaline semen may be Art. 3. Noncompliance with the require- distributed in Brazil only if collected at Semen ments hereunder shall be a crime pursuant to Collection and Processing Centers-SCPC registered Art. 259 of the Penal Code. with the Ministry of Agriculture, Livestock, and Art. 4. This Normative Instruction shall enter Food Supply-MAPA and which are IN COMPLI- into force on the day of its publication.

MAÇAO TADANO

403

ANNEX I

MINIMUM REQUIREMENTS FOR THE PRODUCTION AND MARKETING OF BOVINE AND BUBALINE SEMEN IN BRAZIL

CHAPTER I Complement Fixation test; (b) TUBERCULOSIS: intradermal tuberculin PRE-QUARANTINE test (simple bovine PPD test or bovine PPD and avian PPD comparative test). 1. To be admitted to a SCPC, animals must Note: Exemption from the performance of be accompanied by an animal movement permit brucellosis and tuberculosis tests is allowed for ani- and must have tested negative in the preceding mals from herds certified as free of these diseases, 60 (sixty) days for the following diseases: in accordance with the Technical Regulations of (a) BRUCELLOSIS: Buffered Acidified Anti- the National Program on Control and Eradication gen test (BAAT) or 2-Mercaptoethanol (2-ME), or of Animal Brucellosis and Tuberculosis. CHAPTER II SIS: one test of prepuce material; (d) TRICHOMONOSIS: one culture of pre- QUARANTINE FOR ADMISSION puce material test. TO A SEMEN COLLECTION AND 4. SCPC resident animals tested positive for PROCESSING CENTER the abovementioned diseases shall be isolated and reevaluated by the Ministry of Agriculture, 2. Before being admitted into a SCPC resi- Livestock, and Food Supply’s Official Veterinary dent herd, all animals shall be subjected to quar- Service. antine for a minimum of 28 days, during which 4.1. Reevaluation will be done through paired time they will be submitted to diagnostic tests for tests recommended by the OIE and through epi- the following diseases: demiologic survey of the establishment; (a) BRUCELLOSIS: negative BAAT or 2-ME or 4.2. An animal tested positive for any of the Complement Fixation tests; abovementioned diseases shall be withdrawn (b) TUBERCULOSIS: negative simple intrader- from the SCPC and sanitary health and inspection mal tuberculin test or bovine PPD and avian PPD measures shall be applied, pursuant to MAPA’s comparative test; current legislation. (c) BOVINE GENITAL CAMPYLOBACTERIOSIS: 4.3. Semen from such animal stored in the three negative culture tests of prepuce material SCPC must be destroyed. collected at minimum seven-day intervals; 4.4. Animals that have been in contact with (d) TRICHOMONOSIS: three negative culture such animal must be also tested again for the dis- tests of prepuce material collected at minimal ease in question. seven-day intervals; (e) BOVINE VIRAL DIARRHOEA (BVD): virus CHAPTER IV isolation negative test and agent identification through immunoflurorescence or immunoper- ADDITION OF ANTIBIOTICS oxidase, or viral antigen detection test. TO SEMEN PROCESSING Note: Before being admitted into the resident herd, all animals must be tested so as to elimi- 5. To each milliliter of frozen semen will be nate the possibility of persistent BVD infection. added bactericide antibiotic mixtures, as follows: 404 Animals tested positive for BVD must be submit- (a) gentamicyn (250 µg), tilosyn (50 µg), lin- ted to a second test after a minimum interval of comicyn (150 µg), and spectinomicyn (300 µg); or 21 days. If tested negative at the second testing, (b) penicillin (500 UI), streptomicyn (500 UI), the animals may be admitted into the SCPC. lincomicyn (150 µg), and spectinomicyn (300 µg). Note: Other antibiotic combinations may be CHAPTER III used, provided their efficacy has been proven, and subject to authorization from the Ministry of RESIDENT HERD Agriculture, Livestock, and Food Supply.

3. A SCPC resident herd must be submitted CHAPTER V to diagnostic tests at least once a year and test negative for the following diseases: GENERAL DISPOSITIONS

(a) BRUCELLOSIS: BAAT or 2-ME or Comple- 6. SCPC resident animals must be continu- ment Fixation test; ously isolated from animals in different sanitary (b) TUBERCULOSIS: simple intradermal tu- conditions. berculin test or bovine PPD and avian PPD com- 7. Animals may be released from quarantine parative test; to join the resident herd after 28 days in isolation (c) BOVINE GENITAL CAMPYLOBACTERIO- and the performance of the sanitary tests. 8. Animals that have left the herd must be pursuant to the requirements under the Tech- subjected to the quarantine procedures before nical Regulations of the National Program on readmission. Control and Eradication of Animal Brucellosis 9. Laboratory tests must be performed by and Tuberculosis. laboratories recognized or accredited by the Min- 12. Tuberculosis tests should be performed istry of Agriculture, Livestock, and Food Supply’s only after a minimum of 60 (sixty) days after the Animal Health and Inspection Department. last testing. 10. Brucellosis testing of animals in quaran- 13. The fast agglutination serum test for bru- tine should be done at least 30 days after pre- cellosis may be used as long as the National Pro- quarantine testing. gram on Brucellosis Control and Eradication still 11. Tuberculosis testing should be done permits the use of this technique in the country.

ANNEX II

VETERINARIAN’S STATEMENT

I, ______, a veterinarian registered with the CRMV/ CFMV under No. ______, certify that the animal(s) identified below, belonging to Mr. ______, and which are located on the ______property situated in the Municipality of ______, State of ______, comes/come from a herd certified by the Ministry of Agriculture, Livestock, and Food Supply as free of brucellosis and tuberculosis.

ANIMAL(S) IDENTIFICATION

ANIMALS’ NAME OR REGISTRATION Nº. BREED AGE (months) 405

Place and date:

Veterinarian’s signature and seal

Please attach proof of the herd’s certification as free of brucellosis or tuberculosis.

Delete items that do not apply. NORMATIVE INSTRUCTION No. 17 OF APRIL 10, 2003

Published in the Official Gazette of April 14, 2003 Section 1, Page 2

Incorporates into the national legislation the “Zoosanitary Requirements and Certificates for Goat Trade among Mercosur State Parties.”

THE MINISTRY OF AGRICULTURE, LIVESTOCK RESOLVES: AND FOOD SUPPLY’S ANIMAL AND PLANT HEALTH Art. 1. To incorporate into the national legis- AND INSPECTION SECRETARY, by virtue of the lation the “Zoosanitary Requirements and Certifi- powers vested in him under Art. 83, IV of the cates for Caprine Animals Trade among Mercosur Office’s Internal Regulations approved under State Parties” approved under MERCOSUR GMC Ministerial Administrative Ruling No. 574 of De- Resolution No. 42/02 and transcribed in the An- cember 8, 1998, having in view the provisions nex hereto. of the Ouro Preto Protocol and Proceeding No. Art. 2. This Normative Instruction shall enter 21000.000629/2003-81, into force on the day of its publication.

MAÇAO TADANO

ANNEX I

ZOOSANITARY REQUIREMENTS AND CERTIFICATES FOR CAPRINE ANIMALS TRADE AMONG MERCOSUR STATE PARTIES

CHAPTER I tablishment where the animals stayed in quarantine prior to exportation. GENERAL DISPOSITIONS Art. 3. Animals destined for exportation must be held in isolation for a period of 30 406 Art. 1. All trade in live goats among Merco- (thirty) days prior to shipment, in facilities ap- sur State Parties must be subject to this Resolu- proved and under official supervision, pursuant tion and should be accompanied and support- to Mercosur’s current norms. ed by ZOOSANITARY CERTIFICATES for goats for During quarantine and according to their reproduction, fattening (only castrated animals) category or purpose, the animals shall be sub- or immediate slaughter, as appropriate. Said jected to the diagnostic tests specified under certificates are issued by the Official Veterinary Art. 10.6 hereof, performed in an official labo- Service, approved under this Resolution, and ratory or in a laboratory accredited by the Of- transcribed in Annex II. ficial Veterinary Services, as a requirement for Art. 2. For the purposes hereunder, the the issuance of the pertinent official zoosani- definitions in the International Epizooties Of- tary certificate. fice-OIE’s International Zoosanitary Code shall Art. 4. The diagnostic test results in sup- apply, as shall the following definitions: port of the caprine zoosanitary certificates shall ESTABLISHMENT OF ORIGIN: establish- be valid for 30 (thirty) days as of the collection ment where the animals were born or have of samples; this deadline may be extended for remained in the 12 (twelve) months prior to 15 (fifteen) days. The zoosanitary certificates being exported; and shall be valid for 10 (ten) days as of the date on ESTABLISHMENT OF PERMANENCE: the es- which they were signed. Art. 5. Animals from countries, regions, Certification pertaining to these diseases or establishments that have been officially shall be for a minimum of eight years. declared disease free pursuant to the speci- As regards transmissible spongiform en- fications set forth for each disease under the cephalopathy, the State Party’s Official Veteri- pertinent chapters of the OIE International nary Service must certify that the animals were Zoosanitary Code shall be exempted from the born and raised in said State Party or have requirement of diagnostic tests for the diseases stayed in another country enjoying similar san- of which they have been declared free. itary conditions, and the animals’ ascendants Art. 6. As regards goats from a State Party, were born in the State Party or were imported which have participated in an international ex- from a country enjoying similar sanitary condi- position in the same State Party, in compliance tions in the previous eight years. with the sanitary requirements for their subse- The Official Veterinary Service of the State quent exportation, their permanence at the ex- Party of origin or permanence should also cer- position shall be considered as an extension of tify as follows: the exportation quarantine and after the event’s 1. That the animals were born and raised closing they may be exported directly to the des- in the State Party of origin or have stayed in an- tination country, provided no case of transmis- other State Party in a similar sanitary condition sible disease has occurred during the event. as the State Party from which they come; Art. 7. The direct shipment of goats from 2. That in the case of animals imported for one international livestock exposition to anoth- reproduction from third countries, the animals er shall be permitted under sanitary conditions have remained for the previous 90 (ninety) days agreed between the pertinent Official Veteri- in the State Party where they come from, or nary Services. zone thereof; Art. 8. Animals should be transported in 3. That at the establishment of origin or accordance with current Mercosur norms. quarantine no case of transmissible diseases has occurred in the 90 (ninety) days before shipment; CHAPTER II 4. That, as regards foot-and-mouth disease, blue tongue, vesicular stomatitis, and caprine SANITARY CERTIFICATION arthritis-encephalitis, the procedures set forth 407 under the pertinent chapter of the OIE Interna- Art. 9. The State Party’s Official Veterinary tional Zoosanitary Code have been adopted; Service must officially certify that the State 5. That the animals to be exported have Party of origin or permanence, or zone thereof, been vaccinated against anthrax and blackleg or the animals’ country of origin, as applicable, between 15 (fifteen) and 180 (one hundred has remained free of the diseases listed below eighty) days prior to shipment; and for a period recommended by the OIE in its In- 6. That while in quarantine the animals ternational Zoosanitary Code for each one: have been subjected and tested negative to the Foot-and-mouth disease; following diagnostic tests, as provided under Sheep pox; Art. 3 hereunder: Pest des petits ruminants 6.1. FOOT-AND-MOUTH DISEASE Contagious agalactia; Tests shall be agreed by the Official Veteri- Rift Valley fever; nary Services taking into account the sanitary Maedi Visna; status of the origin or destination region, coun- Border disease; try, or zone as provided under the OIE Interna- Contagious caprine pleuropneumonia; tional Zoosanitary Code as regards foot-and- and mouth disease. Scrapie. With respect to goats to be exported to an foot-and-mouth disease free State Party or zone to treatment against both internal and external thereof, the destination State Party’s Official parasites within thirty days prior to shipment. Veterinary Services will specify the sanitary con- 8. That the animals being exported are not ditions to be satisfied in accordance with the discardable animals under any program on dis- OIE International Zoosanitary Code. ease control and/or eradication under imple- 6.2. BRUCELLOSIS mentation in the State Party from which they Brucella abortus: males and females aged are being exported. over 180 (one hundred eighty) days. 9. That the animals did not show any clini- (a) Rose Bengal test cal symptom of infectious disease at the time (b) Complement fixation test of shipment. 6.3. BLUE TONGUE 10. That in the animals’ State Party of ori- (a) Agar-gel immunodiffusion, or gin it is prohibited to feed ruminants with meat (b) ELISA. and bone meals and other feed containing pro- 6.4. CAPRINE ARTHRITIS/ENCEPHALITIS teins of a ruminant origin. (a) Agar-gel immunodiffusion, or Art. 11. In respect of anabolyzing sub- (b) ELISA stances, the importing State Party’s national 7. That the animals have been submitted regulations thereon shall prevail.

ANNEX II

ZOOSANITARY CERTIFICATES

ZOOSANITARY CERTIFICATE FOR EXPORTATION OF GOATS FOR REPRODUCTION

Certificate No.: Date issued: Expiration date: 408

I. ORIGIN State Party: State: Establishment of origin: Establishment adress: Exporter: Exporter’s address: II. DESTINATION State Party: State: Destination establishment: Destination establishment’s address: Importer: Importer’s address:

III. TRANSPORTATION Means of transportation: Point of exit:

IV. ANIMALS’ IDENTIFICATION

Total number of animals No. by order Identification Breed Gender Age (*) Observations nº. (*) 1 2 3 4 5 6 7 8 409 9 10 11 12 13 14 15 16 17 18

(*) As applicable Note: This page may be replaced by a list signed by the Official Veterinarian and attached to the certificate. V. SANITARY INFORMATION curred in the 90 (ninety) days prior to shipment. The undersigned official veterinary certi- 8. That the animals were vaccinated anthrax fies that: and blackleg between 15 (fifteen) and 180 (one 1. The State Party is in compliance with the hundred eighty) days prior to shipment. conditions set forth under Art. 9 of Annex I to 9. That the animals were submitted to treat- GMC Resolution No. 42/02 on “Zoosanitary Re- ment for internal and external parasites within quirements and Certificates for Caprine Animals 30 (thirty) days prior to shipment. Trade among Mercosur State Parties.” 10. That the animals were held in isolation 2. The animals were born and raised in for 30 (thirty) days before being exported, in ap- the State Party of origin or zone thereof or proved facilities under official supervision, and have stayed in another State Party or zone en- tested negative for the following diseases: joying similar sanitary conditions. That in the 10.1. BRUCELLOSIS case of animals imported from third countries, Brucella abortus: males and females aged the latter are in compliance with the pertinent over 180 (one hundred eighty) days. Mercosur sanitary requirements, and that the a) Rose Bengal test animals have spent the last 90 (ninety) days b) Complement fixation test in the State Party or zone thereof from where 10.2. BLUE TONGUE they come. a) Agar-gel immunodiffusion, or 3. That as regards vesicular stomatitis, pro- b) ELISA. cedures were adopted in accordance with the 10.3. CAPRINE ARTHRITIS-ENCEPHALITIS provisions under the pertinent chapter of the a) Agar-gel immunodiffusion, or OIE International Zoosanitary Code. b) ELISA 4. That as regards blue tongue, procedures 11. That the animals being exported are were adopted in accordance with the provisions not discardable animals under any program on under the pertinent chapter of the OIE Interna- disease control and/or eradication under imple- tional Zoosanitary Code. mentation in the State Party from which they are 5. That as regards foot-and-mouth disease, being exported. procedures were adopted in accordance with the 12. That in respect of anabolyzing substanc- provisions under the pertinent chapter of the es, the importing State Party’s national regula- OIE International Zoosanitary Code. tions thereon shall prevail. 410 6. That as regards caprine arthritis-enceph- 13. That animals come from a State party or alitis, procedures were adopted in accordance zone thereof or from an establishment that has with the provisions under the pertinent chapter been officially declared free of one or more than of the OIE International Zoosanitary Code. one disease pursuant to the provisions under the 7. That at the establishment of origin and/or pertinent chapter of OIE International Zoosani- quarantine, no case of transmissible diseases oc- tary Code as regards the following diseases: DISEASE OFFICIAL DOCUMENT DATE

OBSERVATIONS:

Place and date , _____/_____/_____

Official stamp

Official veterinary’s signature and stamp

VI. CERTIFICATION FOR RETURN FROM EXPOSITIONS The undersigned official veterinary certifies that:

No cases of transmissible diseases susceptible of affecting the species occurred during the event.

Place and date , _____/_____/_____

Official stamp 411

Official veterinary’s signature and stamp VII. ANIMALS’ SHIPMENT The animals were checked at the time of shipment and showed no clinical signs of infectious diseases and were free of external parasites. The animals are being transported pursuant to current Mercosur norms.

SHIPMENT PLACE: SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No.

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

412 ZOOSANITARY CERTIFICATE FOR EXPORTATION OF GOATS FOR FATTENING (Only castrated males)

Certificate No. Date issued Expiration date

I. ORIGIN State Party State Establishment of origin Establishment of origin’s address Exporter Address

II. DESTINATION State Party State Destination establishment Destination establishment’s address Importer Importer’s address

III. TRANSPORTATION Means of transportation 413 Point of exit

IV. ANIMALS’ IDENTIFICATION

Total number of animals No. by order Identification Breed Gender Age (*) Observations nº. (*) 1 2

(*) As applicable Note: This page may be replaced by a list signed by the official veterinary and attached to the certificate. V. SANITARY INFORMATION 8. That at the establishment of origin and/or 1. The undersigned official veterinary certi- quarantine, no case of transmissible diseases oc- fies that: curred in the 90 (ninety) days prior to shipment. 2. The State Party is in compliance with the 9. That the animals were vaccinated against conditions set forth under Art. 9 of Annex I to anthrax and blackleg between 15 (fifteen) and 180 GMC Resolution No. 42/02 on “Zoosanitary Re- (one hundred eighty) days prior to shipment. quirements and Certificates for Caprine Animals 10. That the animals were submitted to treat- Trade among Mercosur State Parties.” ment for internal and external parasites within 3. The animals were born and raised in the 30 (thirty) days prior to shipment. State Party of origin or zone thereof or have 11. That the animals being exported are stayed in another State Party or zone of simi- not discardable animals under any program on lar sanitary status. That in the case of animals disease control and/or eradication under imple- imported from third countries, the latter are in mentation in the State Party from which they are compliance with the pertinent Mercosur sanitary being exported. They are all castrated animals. requirements, and that the animals have spent 12. That in respect of anabolyzing substanc- the last 90 (ninety) days in the State Party or zone es, the importing State Party’s national regula- thereof from where they come. tions thereon shall prevail. 4. That as regards vesicular stomatitis, pro- 13. That the animals were held in isolation cedures were adopted in accordance with the for 30 (thirty) days before being exported, in ap- provisions under the pertinent chapter of the OIE proved facilities under official supervision, and International Zoosanitary Code. tested negative for the following diseases: 5. That as regards blue tongue, procedures 13.1. BLUE TONGUE were adopted in accordance with the provisions a) Agar-gel immunodiffusion, or under the pertinent chapter of the OIE Interna- b) ELISA. tional Zoosanitary Code. 13.2. CAPRINE ARTHRITIS/ENCEPHALITIS 6. That as regards foot-and-mouth disease, a) Agar-gel immunodiffusion, or procedures were adopted in accordance with the b) ELISA provisions under the pertinent chapter of the OIE 14. That animals come from a State party or International Zoosanitary Code. zone thereof or from an establishment that has 7. That as regards caprine arthritis-enceph- been officially declared free of one or more than 414 alitis, procedures were adopted in accordance one disease pursuant to the provisions under the with the provisions under the pertinent chapter pertinent chapter of OIE International Zoosani- of the OIE International Zoosanitary Code. tary Code as regards the following diseases: DISEASE OFFICIAL DOCUMENT DATE

OBSERVATIONS:

Place and date , _____/_____/_____

Official stamp

Official veterinary’s signature and stamp

VI. ANIMALS’ SHIPMENT The animals were checked at the time of shipment and showed no clinical signs of infectious diseases and were free of external parasites. The animals are being transported pursuant to current Mercosur norms.

SHIPMENT PLACE: SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No.

Place and date , _____/_____/_____ 415

Official Stamp

Official veterinary’s signature and stamp ZOOSANITARY CERTIFICATE FOR EXPORTATION OF GOATS FOR IMMEDIATE SLAUGHTERING

Certificate No. Date issued Expiration date

I. ORIGIN State Party State Establishment of origin Establishment of origin’s address Exporter Address

II. DESTINATION State Party State Destination establishment Destination establishment’s address Importer Importer’s address

III. TRANSPORTATION Means of transportation Point of exit 416 IV. ANIMALS’ IDENTIFICATION Total number of animals No. by order Identification No. Breed Gender Age Observations Machos Fêmeas

V- SANITARY INFORMATIONS similar sanitary status. The undersigned official veterinary certifies that: 3. That as regards vesicular stomatitis, pro- 1. The State Party is in compliance with the cedures were adopted in accordance with the conditions set forth under Art. 9 of Annex I to provisions under the pertinent chapter of the OIE GMC Resolution No. 42/02 on “Zoosanitary Re- International Zoosanitary Code. quirements and Certificates for Caprine Animals 4. That as regards blue tongue, procedures Trade among Mercosur State Parties.” were adopted in accordance with the provisions 2. The animals were born and raised in under the pertinent chapter of the OIE Interna- the State Party of origin or zone thereof or tional Zoosanitary Code. have stayed in another State Party or zone of 5. That as regards foot-and-mouth disease, procedures were adopted in accordance with the curred in the 90 (ninety) days prior to shipment. provisions under the pertinent chapter of the OIE 8. That the animals being exported are not International Zoosanitary Code. discardable animals under any program on dis- 6. That as regards caprine arthritis-enceph- ease control and/or eradication under imple- alitis, procedures were adopted in accordance mentation in the State Party from which they are with the provisions under the pertinent chapter being exported. of the OIE International Zoosanitary Code. 9. That in respect of anabolyzing substances, 7. That at the establishment of origin and/or the importing State Party’s national regulations quarantine, no case of transmissible diseases oc- thereon shall prevail.

OBSERVATIONS:

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

SHIPMENT PLACE: SEAL No. VEHICLE’S TAG No. 417 SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No. SEAL No. VEHICLE’S TAG No.

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp SDA NORMATIVE INSTRUCTION No. 54 OF SEPTEMBER 17, 2002

Published in the Official Gazette of September 19, 2002 Section 1, Page 8

Approves zoosanitary requirements for the importation of swine semen. Not applicable to Mercosur States Parties.

THE SECRETARY OF AGRICULTURE AND LIVE- the Annex which is part of this Normative In- STOCK HEALTH AND INSPECTION OF THE MINIS- struction. TRY OF AGRICULTURE, LIVESTOCK AND FOOD SUP- Sole paragraph This Normative Instruction PLY, proceeding from his attributions established shall not apply to Member States of MERCOSUL. by Article 38, Item IV, of the Secretary’s Internal Art. 2. The Animal Health and Inspection Regulation, approved by Ministerial Decree No. Department (DDA – Departamento de Defesa 574 of December 8, 1998, considering process Animal), where necessary, shall edit additional No. 21000.008028/2001-54, decides: rules for this Normative Instruction. Art. 1. Approve animal health requirements Art. 3. This Normative Instruction shall come for importation of swine semen, as described in into effect from the date of its publication.

LUIZ CARLOS DE OLIVEIRA

ANNEX

BRAZIL’S ANIMAL HEALTH REQUIREMENTS FOR IMPORTATION OF SWINE SEMEN OF COUNTRIES WHICH ARE NOT MEMBERS OF MERCOSUL

I. GENERAL CONDITIONS veterinarian accredited by the official veterinary 1. Requirements of this Normative Instruc- control service of the exporting country; tion shall be complied by countries recognized 2.4. keeps animals related to production of 418 by the Brazilian Ministry of Agriculture, Livestock sperm only; and Food Supply (MAPA – Ministério da Agricul- 2.5. is isolated from establishments that tura, Pecuária e Abastecimento) as free of African rearing or slaughter pigs; swine fever, swine vesicular disease, rinderpest 2.6. has strict entrance control for visitors; and foot-and-mouth disease (FMD). 2.7. provides protective clothing and boots 2. The semen for export to Brazil shall be col- for employees engaged in semen gathering, pro- lected in a Center for Semen Collection and Pro- cessing and storage; cessing (CSCP) that: 2.8. has appropriate facilities to accommo- 2.1. is registered with the Veterinary Control date the semen donors at collection; Service of the exporting country; 2.9. has separate facilities to perform semen 2.2. operates under the surveillance of the collection, processing and storage. official veterinary Control Service of the export- 3. Every import of swine semen shall be pre- ing country to control periodically animal’s viously authorized by the Ministry of Agriculture, health and welfare conditions, as well as the Livestock and Food Supply. methods used for collection, processing and 4. Every import of swine semen shall be storage of semen, records made and sanitary accompanied by Animal Health Certificate, de- control of the CSCP; scribed as follow: 2.3. has technical staff, including at least one 4.1. The certificate shall be issued in the official language of the exporting country and in from classical swine fever (CSF-free), recognized Portuguese; as such by MAPA. 4.2. The certificate shall be signed or en- C – CONCERNING SEMEN DONORS dorsed by the Official veterinary Control Service 4. The donor animals shall remain in the ex- of the exporting country; porting country for at least sixty (60) days prior to 4.3. The certificate shall be numbered and semen collection. stamped on each page with the Official veteri- 5. The donor animals must come from fa- nary Control Service’s stamp; cilities located in a non-infected zone of classical 4.4. The certificate form of the exporting swine fever (CSF-free) in accordance with the In- country shall be submitted prior to approval of ternational Animal Health Code of the OIE. the Animal Health and Inspection Department 6. The donor animals must come from facili- (DDA) of the Ministry of Agriculture, Livestock ties free from brucellosis, tuberculosis, Aujeszky’s and Food Supply (MAPA). disease, in accordance with the International Ani- 5. Every collection of donor material for mal Health Code of the OIE. tests required by MAPA shall be supervised by 7. The donor animals must come from facili- an official veterinarian of the exporting country ties where vesicular stomatitis, transmissible gas- or by the veterinarian responsible for the col- troenteritis (TGE), and Teschen disease had not lection center. been reported during the ninety (90) days prior 6. Laboratory tests required by MAPA shall be to semen collection. performed only in a laboratory approved by the 8. The donor animals must come from facili- Official veterinary Control Service of the export- ties free from porcine reproductive and respira- ing country. tory syndrome (PRRS). 7. Straws or ampoules of semen shall be iden- 9. The donors and other animals living in the tified with the registration number, breed of donor collection center must not present any clinical animal, date of collection and name of the CSCP. signs of disease during the thirty (30) days prior II. ANIMAL HEALTH CERTIFICATE to collection, at the time of collection and during The animal health certificate accompanying the thirty (30) days after collection of the semen. the Brazilian imports shall be in accordance with D – CONCERNING DIAGNOSTIC TESTS the model recommended by the International 10. The donor animals shall be tested and Animal Health Code of the World Organization have negative results for the following diseases: 419 for Animal Health (OIE), plus the following health 10.1. Brucellosis – BBAT, ELISA or comple- information: ment fixation test, on entry into CSCP and every six A – CONCERNING THE EXPORTING COUNTRY months thereafter while resident at the center. 1. From the period of collection until the 10.2. Aujeszky’s disease (pseudorabies) – Vi- embarkation of the semen, the country must rus neutralization or ELISA, on entry into CSCP be free from African swine fever, swine vesicular and every six (6) months thereafter while resident disease, rinderpest and foot-and-mouth disease, at the center. according to recommendations of International 10.3. Porcine reproductive and respiratory Animal Health Code of the OIE. syndrome (PRRS) – ELISA, at least thirty (30) days B – CONCERNING THE CENTER FOR SEMEN prior to collection of the semen and then between COLLECTION AND PROCESSING (CSCP) fifteen (15) and sixty (60) days after collection. 2. The Center for Semen Collection and Pro- E – CONCERNING THE SEMEN cessing (CSCP), where the to-be-exported semen 11. The semen must be collected, processed was collected, complies with item I.2, Appendix and stored in a manner consistent with recommen- of SDA Normative Instruction No...... , .. dations of the International Animal Health Code...... 2002. 12. Appropriate antibiotic mixes (such as 3. The CSCP, where the to-be-exported se- penicillin, dihydrostreptomycin and polymyxin) men was collected, is located in a zone free at effective levels must be used in frozen semen to prevent the presence of contaminating bac- narian responsible for the collection center. terial agents. Note: If the country has achieved free status 13. The semen must be stored in semen tanks for any of the diseases listed in D.10, tests would previously cleaned and disinfected for a period of not be necessary for the disease agent. In this at least thirty (30) days prior to embarkation in a case, the exporting country must obtain recogni- locked room under the direct control of the veteri- tion from MAPA for this certification.

NORMATIVE INSTRUCTION SDA No. 39 OF JUNE 17, 2002

Published in the Official Gazette of June 24, 2002 Section 1, Page 15

Adopts Mercosur GMC Resolution No. 51/01, which approves the “Zoosanitary Requirements for Sheep Trading among Mercosur State Parties.”

THE MINISTRY OF AGRICULTURE, LIVESTOCK 21000.000313/2002-99, AND FOOD SUPPLY’S ANIMAL AND PLANT HAELTH RESOLVES: AND INSPECTION SECRETARY, by virtue of the Art. 1. Adopt Mercosur GMC Resolution No. powers vested in him under Art. 83, IV of the 51/01, which approves the “Requirements and Office’s Internal Regulations approved under Certificated for Ovine Trade among Mercosur Ministerial Administrative Ruling No. 574 of De- State Parties” as well as the Resolution’s annexes. cember 8, 1998, having in view the provisions Art. 2. This Normative Instruction shall enter of the Ouro Preto Protocol and Proceeding No. into force on the day of its publication.

LUIZ CARLOS DE OLIVEIRA

MERCOSUR/GMC/RES.NO.51/01 Art. 2. For the purposes hereunder, the “REQUIREMENTS AND CERTIFICATED FOR Zoosanitary Certificates listed below, pursuant 420 OVINE ANIMALS TRADE AMONG MERCOSUR to Annex II, are hereby approved and form part STATE PARTIES.” hereof. (REVOKES GMC RES Nº. 66/94) - “Zoosanitary Certificate for exporta- HAVING IN VIEW the Treaty of Asunción, the tion of sheep for reproduction;” Ouro Preto Protocol, Common Market Council - “Zoosanitary Certificate for expor- Decision No. 6/96, and Common Market Group tation of sheep for fattening (Only castrated Resolution No. 66/94; males.)” WHEREAS there is a need to update the san- - “Zoosanitary Certificate for exporta- itary requirements and the certificates called tion of sheep for immediate slaughtering,” for under GMC Resolution No. 66/94 for ovine Art. 3. The States Parties shall enforce the trade in Mercosur, as well as the pertinent zoo- legal, regulation, and administrative provisions sanitary certificates, for implementation of this Resolution through THE COMMON MARKET GROUP RESOLVES: the following bodies: Art. 1. To approve the “Requirements and Argentina: Department of Agriculture, Certificated for Ovine Animals Trade among Livestock, Fisheries, and Food Supply-SAGPyA- Mercosur State Parties,” pursuant to Annex I National Agriculture and Food Health and hereto, which form part hereof. Said require- Quality Service-SENASA; ments are the only requirements to be enforced Brazil: Ministry of Agriculture, Livestock, in trade among the States Parties. and Food Supply-MAPA-Agriculture, Animal and Plant Health and Inspection Secretariat -SDA; Art. 4. GMC Resolution no. 66/94 is hereby Paraguay: Ministry of Agriculture and Live- revoked. stock-MAG-State Livestock Department-SSEG- Art. 5. The Mercosur States Parties shall National Animal Health Service-SENACSA; and incorporate this Resolution into their national Uruguay: Ministry of Livestock, Agriculture, and legislation by March 31, 2002. Fisheries-MGAP-Livestock Services Office-DGSG. XLIV GMC, Montevideo, December 5, 2001.

ANNEX I

REQUIREMENTS AND CERTIFICATED FOR OVINE ANIMALS TRADE AMONG MERCOSUR STATE PARTIES.

CHAPTER I States Parties shall be valid for 30 (thirty) days as of the date samples are collected and may GENERAL DISPOSITIONS be extended for another 15 (fifteen) days, while the zoosanitary certificates shall be valid for 10 Art. 1. All live sheep trade among Mercosur (ten) days as of the day they are signed. State Parties must comply with this Resolution and Art. 5. Animals from countries, regions, must be accompanied and supported by the perti- or establishments officially declared free ac- nent ZOOSANITARY CERTIFICATES approved under cording to the specifications pertaining to each this Resolution and forming part of Annex II, per- disease pursuant to the pertinent chapters of taining to sheep for reproduction, fattening (only the OIE International Zoosanitary Code are ex- castrated males), or immediate slaughtering. empted from diagnostic testing for the diseases Art. 2. For the purposes hereunder, the of which they have been declared free. definitions in the World Organisation for Animal Art. 6. As regards sheeps from a State Par- Health-OIE’s International Zoosanitary Code shall ty, which are participating in an international apply, as well as the following definitions: exposition in said State Party in compliance Establishment of Origin: establishment where with the sanitary requirements for subsequent the animals were born or have remained during exportation, their stay at the exposition shall 421 the 12 (twelve) months prior to being exported; be considered as an extension of quarantine, Permanence Establishment: location and they may, at the close of the event, be where the animals were held in quarantine exported directly to the destination country, prior to being exported. provided no case of transmissible disease has Art. 3. Animals destined for exportation occurred during the event. must be held in isolation for 30 (thirty) days prior Art. 7. The direct transfer of sheeps between to shipment, in facilities officially approved and international livestock expositions shall be per- supervised pursuant to current Mercosur norms. mitted under sanitary conditions agreed be- During this quarantine period, the animals must tween the respective Official Veterinary Services. be subjected, in accordance with their category Art. 8. The animals must be transported as or destination, to the diagnostic tests referred to provided under current Mercosur norms. under Art. 10.6, performed at an official laboratory or at a laboratory accredited by the Official CHAPTER II Veterinary Services, so that the pertinent zoosanitary certificate may be issued. SANITARY CERTIFICATION Art. 4. The laboratory test results that support an ovine zoosanitary certificate issued by Art. 9. The Mercosur State Party’s Official the Official Veterinary Services of Mercosur Veterinary Service should officially certify that the State Party or zone of the State Party of origin been vaccinated against anthrax and blackleg or permanence and the animals’ country of ori- between 15 (fifteen) and 180 (one hundred gin, if applicable, have remained free of the dis- eighty) days prior to shipment; and eases listed below for the period recommended 6. That while in quarantine the animals by the OIE International Zoosanitary Code: have been subjected to and tested negative for the following diagnostic tests, as provided un- - foot-and-mouth disease der Art. 3 hereunder: - sheep pox 6.1. FOOT-AND-MOUTH DISEASE - pest des petits ruminants Tests shall be agreed by the Official Veteri- - contagious agalactia nary Services taking into account the sanitary - Maedi-Visna; status of the origin or destination region, coun- - Rift Valley fever try, or zone as provided under the OIE Interna- - Ovine pulmonary adenomatosis tional Zoosanitary Code as regards foot-and- - Border disease mouth disease. - Scrapie. With respect to sheep to be exported to a foot-and-mouth disease free State Party or zone Certification must be for a minimum of thereof, the destination State Party’s Official eight years. Veterinary Services will specify the sanitary con- As regards transmissible spongiform en- ditions to be satisfied in accordance with the cephalopathy, the State Party’s Official Veteri- OIE International Zoosanitary Code. nary Service must certify that the animals were 6.2. BRUCELLOSIS born and raised in said State Party or have Brucella ovis: males aged over 180 stayed in another country enjoying similar san- (one hundred eighty) days. itary conditions, and the animals’ ascendants a) Agar-gel immunodiffusion, or were born in the State Party or were imported b) Complement fixation test, or from a country enjoying similar sanitary condi- c) ELISA. tions in the previous eight years. Brucella abortus: males and females Art. 10. The Official Veterinary Service of aged over 180 (one hundred eighty) days. the State Party of origin or permanence should a) Rose Bengal test also certify as follows: b) Complement fixation test 422 1. That the animals were born and raised 6.3. BLUE TONGUE in the State Party of origin or have stayed in an- a) Agar-gel immunodiffusion, or other State Party in a similar sanitary condition b) ELISA. as the State Party from which they come; 6.4. CAPRINE ARTHRITIS/ENCEPHALITIS 2. That in the case of animals imported for a) Agar-gel immunodiffusion, or reproduction from third countries, the animals b) ELISA have remained for the previous 90 (ninety) days 7. That the animals have been submitted in the State Party where they come from, or to treatment against both internal and external zone thereof; parasites within thirty days prior to shipment. 3. That at the establishment of origin or 8. That the animals being exported are not quarantine no case of transmissible diseases has discardable animals under any program on dis- occurred in the 90 (ninety) days before shipment; ease control and/or eradication under imple- 4. That, as regards foot-and-mouth disease, mentation in the State Party from which they blue tongue, vesicular stomatitis, and caprine are being exported. arthritis-encephalitis, the procedures set forth 9. That the animals did not show any clini- under the pertinent chapter of the OIE Interna- cal symptom of infectious disease at the time tional Zoosanitary Code have been adopted; of shipment. 5. That the animals to be exported have 10. That in the animals’ State Party of origin it is prohibited to feed ruminants with meat Art. 11. In respect of anabolyzing sub- and bone meals and other feed containing pro- stances, the importing State Party’s national teins of ruminant origin. regulations thereon shall prevail.

ANNEX II

ZOOSANITARY CERTIFICATE FOR SHEEP EXPORTATION

FOR REPRODUCTION Certificate No. Date issued Expiration date

I – ORIGIN State Party Province, State, Department Establishment of origin Address Exporter Address

II – DESTINATION State Party Province, State, Department 423 Establishment of origin Address Importer Address

III – TRANSPORTATION Means of transportation Exit point

IV – ANIMALS’ IDENTIFICATION Nº. of animals Breed Age Observations Males Females Total No. of animals No. by order Identification No. (*) Breed Gender Age (*)

Note: This page may be replaced by a list signed by the Official Veterinarian and attached to the certificate.

V – SANITARY INFORMATION 7. That at the establishment of origin and/or The undersigned official veterinary certifies quarantine, no case of transmissible diseases oc- that: curred in the 90 (ninety) days prior to shipment. 1. The State Party is in compliance with the 8. That the animals were vaccinated against conditions set forth under Art. 9 of Annex I to anthrax and blackleg between 15 (fifteen) and GMC Resolution No. 42/02 on “Zoosanitary Re- 180 (one hundred eighty) days prior to ship- quirements and Certificates for Ovine Animals ment. Trade among Mercosur States Parties.” 9. That the animals were submitted to treat- 2. The animals were born and raised in the ment for internal and external parasites within State Party of origin or zone thereof or have 30 (thirty) days prior to shipment. stayed in another State Party or zone enjoying 10. That the animals were held in isolation similar sanitary conditions. That in the case of for 30 (thirty) days before being exported, in ap- animals imported from third countries, they are proved facilities under official supervision, and in compliance with the pertinent Mercosur sani- tested negative for the following diseases: tary requirements, and that the animals have 10.1. BRUCELLOSIS 424 spent the last 90 (ninety) days in the State Party Brucella ovis: males aged over (180 one hun- or zone thereof from where they are being ex- dred eighty) days. ported. a) Agar-gel immunodiffusion, or 3. That as regards vesicular stomatitis, pro- b) Complement fixation test cedures were adopted in accordance with the c) ELISA. provisions under the pertinent chapter of the Brucella abortus: males and females aged OIE International Zoosanitary Code. over 180 (one hundred eighty) days. 4. That as regards blue tongue, procedures a) Rose Bengal test were adopted in accordance with the provisions b) Complement fixation test under the pertinent chapter of the OIE Interna- 10.2 BLUE TONGUE tional Zoosanitary Code. a) Agar-gel immunodiffusion, or 5. That as regards foot-and-mouth disease, b) ELISA. procedures were adopted in accordance with the 10.3 CAPRINE ARTHRITIS-ENCEPHALITIS provisions under the pertinent chapter of the a) Agar-gel immunodiffusion, or OIE International Zoosanitary Code. b) ELISA 6. That as regards caprine arthritis-enceph- 11. That the animals being exported are alitis, procedures were adopted in accordance not discardable animals under any program with the provisions under the pertinent chapter on disease control and/or eradication under of the OIE International Zoosanitary Code. implementation in the State Party from which they are being exported. zone thereof or from an establishment that has 12. That in respect of anabolyzing substanc- been officially declared free of one or more than es, the importing State Party’s national regula- one disease pursuant to the provisions under the tions thereon shall prevail. pertinent chapter of OIE International Zoosani- 13. That animals come from a State party or tary Code as regards the following diseases:

Official Date OBSERVAÇÕES:

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

VI. CERTIFICATION FOR RETURN FROM EXPOSITIONS The undersigned official veterinary certifies that: No cases of transmissible diseases susceptible of affecting the species occurred during the event.

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp 425 VI. ANIMALS’ SHIPMENT The identified animals were checked at the time of shipment and showed no clinical signs of infectious diseases and were free of external parasites. The animals are being transported pursuant to current Mercosur norms.

SHIPMENT POINT ______SEAL No. : ______VEHICLE’S TAG No. ______SEAL No. : ______VEHICLE’S TAG No. ______SEAL No. : ______VEHICLE’S TAG No. ______SEAL No. : ______VEHICLE’S TAG No. ______

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

426 ZOOSANITARY CERTIFICATE FOR EXPORTATION OF SHEEP FOR FATTENING (Only castrated males)

Certificate No. Date issued Expiration date

I – ORIGIN State Party Province, State, Department Establishment of origin Address Exporter Address

II – DESTINATION State Party Province, State, Department Establishment of origin Address Importer Address

III – TRANSPORTATION Means of transportation 427 Exit point

IV – ANIMALS’ IDENTIFICATION No. of animals Breed Age Observations Males Females

IV – ANIMALS’ IDENTIFICATION Total of animals No. by order Identification No. (*) Breed Gender Age (*) OBSERVATIONS 1 2 3 4 5 6 7 8 9 10 11 12 13 14

(*) As applicable Note: This page may be replaced by a list signed by the official veterinary and attached to the certificate.

428 V. SANITARY INFORMATION under the pertinent chapter of the OIE Interna- The undersigned official veterinary certi- tional Zoosanitary Code. fies that: 5. That as regards foot-and-mouth disease, 1. The State Party is in compliance with procedures were adopted in accordance with the the conditions set forth under Art. 9 of Annex I provisions under the pertinent chapter of the OIE to GMC Resolution No. 51/021on “Zoosanitary International Zoosanitary Code. Requirements and Certificates for Ovine Trade 6. That as regards caprine arthritis-enceph- among Mercosur State Parties.” alitis, procedures were adopted in accordance 2. The animals were born and raised in the with the provisions under the pertinent chapter State Party of origin or zone thereof or have of the OIE International Zoosanitary Code. stayed in another State Party or zone of similar 7. That at the establishment of origin and/or sanitary status. quarantine, no case of transmissible diseases oc- 3. That as regards vesicular stomatitis, pro- curred in the 90 (ninety) days prior to shipment. cedures were adopted in accordance with the 8. That the animals were vaccinated against provisions under the pertinent chapter of the OIE anthrax and blackleg between 15 (fifteen) and 180 International Zoosanitary Code. (one hundred eighty) days prior to shipment. 4. That as regards blue tongue, procedures 9. That the animals were submitted to treat- were adopted in accordance with the provisions ment for internal and external parasites within 30 (thirty) days prior to shipment. 12.1 BLUE TONGUE 10. That the animals being exported are a) Agar-gel immunodiffusion, or not discardable animals under any program on b) ELISA. disease control and/or eradication under imple- 12.2 CAPRINE ARTHRITIS AND ENCEPHALITIS mentation in the State Party from which they are a) Agar-gel immunodiffusion, or being exported. They are all castrated animals. b) ELISA 11. That in respect of anabolyzing substanc- 13. That animals come from a State party or es, the importing State Party’s national regula- zone thereof or from an establishment that has tions thereon shall prevail. been officially declared free of one or more than 12. That the animals were held in isolation one disease pursuant to the provisions under for 30 (thirty) days before being exported, in ap- the pertinent chapter of OIE International Zoo- proved facilities under official supervision, and sanitary Code as regards the following diseases: tested negative for the following diseases: Disease – Document

Oficial Data

OBSERVAÇÕES:

Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

429 VI. ANIMALS’ SHIPMENT The animals were checked at the time of shipment and showed no clinical signs of infectious diseases and were free of external parasites. The animals are being transported pursuant to current Mercosur norms.

SHIPMENT POINT ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______SEAL No.:______VEHICLE’S TAG No. ______Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

ZOOSANITARY CERTIFICATE FOR EXPORTATION OF SHEEP FOR IMMEDIATE SLAUGHTERING

Certificate No. Date issued Expiration date

I – ORIGIN State Party Province, State, Department Establishment of origin Address Exporter Address

430 II – DESTINATION State Party Province, State, Department Establishment of origin Address Importer Address

III – TRANSPORTATION Means of transportation Exit point

IV – ANIMALS’ IDENTIFICATION No. of animals Breed Age Observations Males Females V – ANIMALS’ IDENTIFICATION Total No. of animals No. by order Identification Nº. (*) Breed Gender Age (*)

OBSERVATIONS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 431 15 16 17 18

(*) As applicable Note: This page may be replaced by a list signed by the official veterinary and attached to the certificate. VI – SANITARY INFORMATION 5. That as regards foot-and-mouth disease, The undersigned official veterinary certi- procedures were adopted in accordance with the fies that: provisions under the pertinent chapter of the OIE 1. The State Party is in compliance with the International Zoosanitary Code. conditions set forth under Art. 9 of Annex I to 6. That as regards caprine arthritis-enceph- GMC Resolution No. 51/01 on “Zoosanitary Re- alitis, procedures were adopted in accordance quirements and Certificates for Ovine Animals with the provisions under the pertinent chapter Trade among Mercosur State Parties.” of the OIE International Zoosanitary Code. 2. The animals were born and raised in the 7. That at the establishment of origin and/ State Party of origin or zone thereof or have or quarantine, no case of transmissible dis- stayed in another State Party or zone of similar eases occurred in the 90 (ninety) days prior to sanitary status. shipment. 3. That as regards vesicular stomatitis, pro- 8. That the animals being exported are not cedures were adopted in accordance with the discardable animals under any program on dis- provisions under the pertinent chapter of the OIE ease control and/or eradication under imple- International Zoosanitary Code. mentation in the State Party from which they are 4. That as regards blue tongue, procedures being exported. were adopted in accordance with the provisions 9. That in respect of anabolyzing substances, under the pertinent chapter of the OIE Interna- the importing State Party’s national regulations tional Zoosanitary Code. thereon shall prevail.

Oficial Data

OBSERVATIONS Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp 432

VII. ANIMALS’ SHIPMENT The animals were checked at the time of shipment and showed no clinical signs of infectious diseases and were free of external parasites. The animals are being transported pursuant to current Mercosur norms. SHIPMENT POINT ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______SEAL No.: ______VEHICLE’S TAG No. ______Place and date , _____/_____/_____

Official Stamp

Official veterinary’s signature and stamp

NORMATIVE INSTRUCTION No. 31 OF MAY 10, 2002

Published in the Official Gazette of May 13, 2002 Section 1, Page 8

All pigs imported must be accompanied by a Zoosanitary Certificate warranting the compliance with the conditions required by the Ministry of Agriculture, Livestock and Food Supply of Brazil.

The SECRETARY OF ANIMAL AND PLANT Paragraph 4. The Sanitary Certificate must HEALTH AND INSPECTION OF THE MINISTRY OF contain the official seal and signature of the lo- AGRICULTURE, LIVESTOCK AND FOOD SUPPLY, in cal Brazilian consulate excepting when, in ac- the use of the powers given to him by the Article cordance with existing bilateral agreement es- 83, incise IV of the Internal Rules of Procedure tablished by presidential decree, the exporting is approved by the Ministerial Administrative Rul- free of this requirement. ing 574 of December 8, 1998 and in view of the Art. 2. A previous authorization from the Ministerial Administrative Ruling 49 of March Ministry of Agriculture, Livestock and Food Supply 11, 1987 and considering the need to harmonize of Brazil is necessary for each import of pigs. the norms for importing pigs for reproduction Sole Paragraph. The imported animals can from foreign countries, and also considering the only be transported by the route indicated by 433 content of the Process 21000.008029/2001-07, the above mentioned importing authorization. resolves: Art. 3. All pigs to be exported to Brazil must Art. 1. All imported pigs must be accom- be submitted to two quarantines: the first at panied by a Sanitary Certificate warranting the their country of origin and the second when en- compliance with the conditions required by the tering Brazil. Ministry of Agriculture, Livestock and Food Sup- Paragraph 1. The quarantine at the country ply of Brazil. of origin is to take place under the supervision of Paragraph 1. The Sanitary Certificate must the local Official Veterinary Service, on a site ap- be issued in both the exporting country’s official proved by that Service and will last no less than language and in Portuguese. twenty-eight (28) days. Paragraph 2. The exporting country must Paragraph 2. The quarantine at destination submit the certificate to the Ministry of Agricul- will take place under supervision of the Ministry ture, Livestock and Food Supply of Brazil for pre- of Agriculture, Livestock and Food Supply of Bra- vious approval. zil on a site approved by the mentioned Ministry Paragraph 3. The Sanitary Certificate of the and will last no less than twenty eight (28) days. imported animals to be supplied by the export- Paragraph 3. The importing party will act as ing party must contain the signature of an of- trustee of the heads of pigs during the quaran- ficial veterinarian. tine in Brazil and it will be subject to the terms of the Article 1265 and followers from the Bra- place at a laboratory belonging to or accredited zil’s Civil Code of Procedures. by the Official Veterinary Service of the export- Paragraph 4. The quarantine will only end and ing country and, on destination, at a laboratory the animals will only be allowed to be taken away belonging to or accredited by the Ministry of Ag- through an official authorization from the Ministry riculture, Livestock and Food Supply of Brazil. of Agriculture, Livestock and Food Supply of Brazil. Art. 7. The certification of country, zone or Art. 4. All pigs to be exported to Brazil will be establishment free of a specific disease will be submitted to all the diagnostic tests required by the given in accordance with the International Ani- Ministry of the Agriculture, Livestock and Food Sup- mal Health Code from the World Organisation ply of Brazil and these tests will take place during for Animal Health (OIE) or with criteria set by the the origin and destination quarantines. Ministry of Agriculture, Livestock and Food Sup- Paragraph 1. In case of any animal present- ply of Brazil. ing a positive required diagnostic test at the Art. 8. The means for transporting the pigs country of origin quarantine, the entire lot in must be clean and disinfected with products ap- quarantine will have denied its export to Brazil. proved by the Official Veterinary Service of the Paragraph 2. In case of any animal present- exporting country. ing a positive required diagnostic test at the des- Art. 9. A model of the health certificate for tination quarantine, the Ministry of the Agricul- exporting pigs to Brazil is enclosed as Annex I of ture, Livestock and Food Supply will act in agree- this Normative Instruction. ment with the established in the Regulation of Art 10. The norms for the approval and Animal Sanitary Health and Inspection and with functioning of the quarantine conditions for ex- all other complementary legislation. porting pigs to Brazil are enclosed as Annex II of Art. 5. The sampling for the diagnostic tests this Normative Instruction. during the quarantine at the country of origin Art. 11. When necessary, the Animal Health will be supervised by the Official Veterinarian and Inspection Department of the Ministry of Service of that country and, at the destination, Agriculture, Livestock and Food Supply of Bra- by the Ministry of Agriculture, Livestock and zil will issue complementary instructions to this Food Supply of Brazil. Normative Instruction. Art. 6. The diagnostic tests required dur- Art. 12. This Normative Instruction will be in ing quarantine at the country of origin will take force on its publication date. 434

LUIZ CARLOS DE OLIVEIRA

ANNEX 1

HEALTH CERTIFICATE FOR EXPORTING BREEDING PIGS TO BRAZIL

I. ANIMAL INDIVIDUAL IDENTIFICATION: The Official Veterinary Service of the ex- Animal number, breed, gender, age porting country certifies that the swine above II. ORIGIN: identified: Name and address of the source farm 1. They are from a farm registered in the Name and address of the exporting party Official Veterinary Service of the exporting III. DESTINATION: country and under the responsibility of a vet- Name and address of the destination farm erinarian accredited by the mentioned service. Name and address of the importing party 2. They are from a country free of mouth- IV. SANITARY INFORMATION and-foot disease, swine vesicular disease, African swine fever and rinderpest as determined by the 6.4 Aujeszky’s Disease – Virus Neutraliza- International Animal Health Code of the OIE. tion Test or ELISA; *** In case of foot-and-mouth disease, it is 6.5 Porcine Reproductive and Respiratory also accepted the certification of Free Zone as Syndrome (PRRS) – two ELISAs with a 21-day determined by the OIE or by the Ministry of Ag- minimum interval; riculture, Livestock and Food Supply of Brazil. 6.6 Transmissible Gastroenteritis – Virus 3. They are from a zone free of classical Neutralization Test or ELISA; swine fever as determined by the International 6.7 Theschovirus Encephalomyelitis – Vi- Animal Health Code of the OIE and recognized rus Neutralization Test; by the Ministry of Agriculture, Livestock and 6.8 Leptospirosis – 1:100 microagglutina- Food Supply of Brazil. tion for L. pomona, L. hardjo, L.wolfi, L. ictero- 4. They are from farms free of brucellosis, haemorrhagiae, L. canicola, L. grippotyphosa, L. tuberculosis and Aujeszky’s disease as deter- tarassovi, L. bratislava e L. ballum mined by the International Animal Health Code Or of the OIE and recognized by the Ministry of Ag- They were submitted to two treatments riculture, Livestock and Food Supply of Brazil. with dihydrostreptomycin (25 mg/kg of live 5. They are from farms with no known weight) fourteen (14) days apart within the clinical occurrence of vesicular stomatitis, twenty eight (28) days prior to shipping. theschovirus encephalomyelitis, transmissible *** The condition of country, zone or farm gastroenteritis, swine influenza, porcine respi- free of a specific disease waives the making ratory coronavirus, porcine epidemic diarrhea, tests for that disease during the quarantine at atrophic rhinitis of swine, swine enzootic pneu- the origin. In this case, the exporting country monia (Mycoplasma hyopneumoniae), swine must obtain the recognition of that condition dysentery (Brachyspira hyodysenteriae) and pig from the Ministry of Agriculture, Livestock and reproductive and respiratory syndrome (PRRS), Food Supply of Brazil. for at least 12 months before shipping. 7. They were treated against internal and *** If the exporting country is free from external parasites with products approved by the diseases listed on items 3, 4, 5 and 6 or if it the Official Veterinary Service of the exporting has zones free from diseases listed on items 4, 5 country within a minimum of five (5) days be- and 6, the mentioned country must obtain the fore shipment. 435 pertinent accreditation from the Ministry of Ag- *** The name of the product and the riculture, Livestock and Food Supply of Brazil. treatment date are to be informed. 6. They were, under official supervision, 8. They were free of clinical signs of any placed apart in a place approved by the Official transmissible diseases and of external para- Veterinary Service of the exporting country for sites on the shipping day. a minimum period of twenty eight (28) days. 9. They were taken directly from the source In this occasion all animals were submitted to farm to the shipping place in a vehicle cleaned diagnostic tests with negative results for the and disinfected with products approved by diseases bellow mentioned: the Official Veterinary Service of the exporting 6.1 Brucellosis – BBAT, ELISA or Comple- country and had no contact whatsoever with ment Fixation Test; animals in adverse sanitary condition. 6.2 Tuberculosis – Comparative Intrader- - Official Stamp mal test with bovine and avian PPD and read - Site and date. 48 hours after inoculation; - Name and signature of the accredited 6.3 Classical Swine Fever – ELISA; veterinarian. ANNEX II

NORMS FOR APPROVING AND OPERATING A QUARANTINE SITE FOR PIGS IN BRAZIL

ON THE CONSTRUCTION DESIGN 4.6 Restrooms away from the quarantine 1. The design for a quarantine site must be facility; submitted to the Ministry of Agriculture, Live- 4.7 Dressing rooms with a room for the in- stock and Food Supply; coming employees to leave their belongings; an- 1.1 Submit the blueprint of the site on a other for them to dress for work and a rest room 1:200 minimum scale. between the two. 1.2 Submit a detailed description of all in- 4.8 A laundry for washing the clothes of the cluded facilities. employees working in the quarantine area; 1.3 Submit the official technical opinion on 4.9 Bays with enough capacity to accommo- the construction site from the party responsible date the pigs; for the applicable environmental policy 4.10 A deposit of swine feed; ON THE QUARANTINE SITE LOCATION 4.11 A cesspool within the specifications of 2. It must be located on an isolated area, the pertinent environmental authorities; far from the urban perimeter and respecting the ON THE WATER QUALITY following distances: 5. The water to be used in the quarantine 2.1. Eight hundred (800) meters away from site must come from known source, not from commercial or subsistence swine farms; natural courses; its tank must be kept protected 2.2. Eight hundred (800) meters away from and be clean and disinfected at least every six farms with other species of animals that may months. represent sanitary risks to domestic pigs; ON THE EFFLUENT TREATMENT 2.3. Eight hundred (800) meters away from 6. It must be done in accordance with all ap- any public road and/or highway; plicable environmental and sanitary norms; 2.4. Two (2) kilometers away from swine ON THE TECHNICAL RESPONSIBILITY slaughterhouses or any other species that may 7. All swine quarantine sites must have a present diseases common to swine. dully accredited veterinarian as its technical re- 436 ON THE LEGAL ASPECTS sponsible; 3. The sites for quarantining imported pigs 7.1 The veterinarian in charge is liable for all must be registered at Brazil’s National Inventory activities carried out in the quarantine site; of Business Companies (CNPJ); 7.2 One (1) veterinarian can only be respon- ON THE CONSTRUCTION sible for one (1) approved swine quarantine site; 4. The quarantine site must be divided into 7.3 During the quarantine time, the respon- physically apart different working areas and it sible veterinarian will work full time in the quar- must be provided of: antine site, no other job being allowed. 4.1 External fences around the quarantine ON THE TESTS PERFORMED DURING QUAR- specific facility with a distance between them of ANTINE not less than ten (10) meters; 8. During their quarantine, the animals will 4.2 Only one gate for controlling the ins and be tested for the following diseases: outs of people and animals; 8.1 Brucellosis: BBAT, ELISA or Complement 4.3 Shallow pools with disinfectant for shoes Fixation Test; and tires at the main entrance; 8.2 Tuberculosis: Comparative Intradermal 4.4 An administrative office physically apart test with bovine and avian PPD and read forty- from any quarantine facility; eight (48) hours after inoculation; 4.5 A canteen for the meals of the employees; 8.3 Classical Swine Fever: ELISA; 8.4 Aujeszky’s Disease: Virus neutralization Livestock and Food Supply. test or ELISA; ON CONTROLLING PERSONNEL AND VISITS 8.5 Porcine Reproductive and Respiratory 11. All movements of personnel in the quar- Syndrome (PRRS): ELISA; antine area will obey the bio-safety criteria; visits 8.6 Transmissible Gastroenteritis: Virus neu- of people foreign to the site are absolutely pro- tralization test or ELISA; hibited without previous authorization from the 8.7 Theschovirus Encephalomyelitis: Virus Ministry of Agriculture, Livestock and Food Sup- neutralization test; ply of Brazil. 8.8 Leptospirosis: 1:100 microagglutination ON DISCARDING MATERIAL for L. pomona, L. hardjo, L.wolfi, L. icterohaemor- 12. The death of any animal during quar- rhagiae, L. canicola, L. grippotyphosa, L. tarassovi, antine must be immediately communicated to L. bratislava e L. ballum. the Ministry of Agriculture, Livestock and Food 9. The imported animals destined to farms Supply, which will supervise the appropriate certified by the Ministry of Agriculture, Livestock necropsy and sample material for lab work. The and Food Supply of Brazil as free of atrophic dead animals will be incinerated or submitted to rhinitis of swine, enzootic pneumonia (Myco- any other method of sanitary discard as decided plasma hyopneumoniae), swine contagious pleu- by the Official Service. ropneumonia (Actinobacillus pleuropneumoniae) ON CONTROLLING RODENTS AND INSECTS and swine dysentery (Brachyspira hyodysente- 13. The quarantine area must have an effi- riae), will be submitted to diagnostic tests for cient system for controlling insects and rodents. these diseases during their quarantine in accor- ON THE RELEASE OF PIGS TO THE FARM dance with the SDA Normative Instruction 19 of 14. The pigs will be released from quaran- February 15, 2002. tine only after authorization from the Ministry of ON THE SAMPLING AND SENDING MATERIAL Agriculture, Livestock and Food Supply. FOR LABORATORY OF THE DOWNTIME 10. The official veterinarian is responsible 15. After the exit of the animals, the quar- for supervising the sampling and shipping of antine site will be submitted to downtime for a material to the laboratory for diagnosing the dis- period of ten (10) days, counted from the date of eases as required by the Ministry of Agriculture, the disinfecting measures. 437 COMPLEMENTARY LEGISLATION

NORMATIVE INSTRUCTION No. 12 OF APRIL 18, 2007

Published in the Official Gazette of April 20, 2007 Section 1, Page 15

Approves sanitary requirements pertaining to females receiving bovine embryos collected in vivo in and regularly imported from the Republic of India, as well as quarantine conditions prior to transfer. NORMATIVE INSTRUCTION No. 32 OF JULY 11, 2007

Published in the Official Gazette of July 12, 2007 Section 1, Page 8

Modifies Normative Instruction No. 6 of February 13, 2006.

NORMATIVE INSTRUCTION No. 6 OF FEBRUARY 13, 2006

Published in the Official Gazette of February 14, 2007 Section 1, Page 14

Modified by Normative Instruction No. 32 of July 11, 2007.

Approves sanitary requirements and technological procedures for the importation – and for the transfer to receiving females on the national territory – of bovine embryos collected in vivo in and imported from the Republic of India.

NORMATIVE INSTRUCTION No. 60 OF NOVEMBER 6, 2002

Published in the Official Gazette of November 17, 2002 Section 1, Page 7

Permits the importation of fertile ostrich eggs only from countries qualified by Brazil’s Ministry of Agriculture, Livestock, and Food Supply-MAPA and from raising establishments recognized by the exporting country’s Official Veterinary Services and by MAPA.

438

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